What is Quality Audit Process? – Advantages, Types

What is Quality Audit Process

What is the Quality Audit process?

To know quality audit meaning plays an important role in an organization first we should understand the true meaning of quality audit. The quality audit can be conducted either by internal auditors or external auditors.  The external audit is conducted by outside audit agencies and is more expensive whereas internal auditors are less expensive.  

Now the question that arises in mind is what quality audit means. The internal quality audit is conducted by the internal staff of the company. For that, the company may give quality audit training to its internal auditors or can hire a qualified quality auditor.  

Because the quality audit is a continuous process, it is better to get the quality audit done internally.  A quality audit is a deep examination of the quality management system (QMS) of an organization. This is conducted by specific quality auditors. The main component of quality system standards is ISO 9001.  

A quality audit is also used to determine whether the scheduled components of a quality audit comply with corporate guidelines such as operating source documentation, federal and state environmental protection laws, regulations, etc. 

A quality audit in itself is a separate form of a financial audit. The primary purpose of a financial audit is to verify the integrity and accuracy of the accounting methods used within the organization. Even so, despite this fundamental difference, it is important to keep in mind that currently there are many traditional roots in the financial audit like the quality audit techniques.

What is Internal Quality Audit?

Internal Quality Audit is a continuous process of a quality audit by the internal quality audit trained staff or by hiring qualified quality auditors. This is the best way to keep control of the improvement of policies and procedures adopted by the management.  

This type of audit helps in the improvement of the working of various departments of the company. The internal quality auditors continuously keep watching to ensure that the quality of all the products is maintained as per specifications. Therefore, the management of every organization must arrange an internal quality audit for the effective working of the company.

Advantages of Quality Audit

A quality audit is very important for any kind of company whether a manufacturing company, trading company, or any other kind of organization.  Below are given some important advantages of quality audit.

  • Increase efficiency
  • Ensure quality of goods and services
  • Review and increase the performance of employees
  • Concentrate on quality standards
  • Timely action for removing errors
  • Ensure a quality management system with valuable suggestions and recommendations.
  • Suggestions on finding out the way to reduce production waste.
  • Examine whether corrective and preventive actions (CAPA) are taken well in time.
  • Recommendations on reducing the cost of quality control.
  • Point out the quality issues that may cause penalties.


Categories  of Quality Audit

1. Procedure audit

Quality audit system, who, where, what, how and when to address the quality system used to produce its product. For example,

  • How is the quality procedure defined? Who is responsible for making the product?
  • Who is responsible for meeting product quality or meeting customers’ needs?
  • What is the limit of management participation in the daily operations of the quality system?
  • What processes are used to guide the organization in its production effort? How are they maintained and updated?
  • Who does that work?
  • Where are the procedures located?
  • What types of processes are used to produce the product (both direct and indirect)?
  • How do the current processes support these direct and indirectly, etc.?

2. Operational audit

Where a quality system audit is normal, an operational audit is very narrowly defined. An operational audit is a procedure for evaluating the operational activities of a company.  

The operational audit is preferred to be connected on a day-to-day basis.   A process audit compares and contrasts the method of producing the final product for written product, work instructions, work-board standards, etc., which is used to direct the manufacturing process responsible for the production of the product.  

The operational audit is also concerned with the validity and overall reliability of the operations.  For example, is the operation continuously generating an acceptable result? Are non-value-added steps taken in the operation?  In the context of meeting the existing and future requirements of key customers, are the present procedures sufficient? 

Keeping this operation in mind, the audit has two operational modes of operation- evaluation, and analysis.  While in evaluation mode, keep this question in front of your mind: Are the workers involved in the production of the operation according to the company’s manufacturing operational plans, procedures, work directions, and workmanship standards?

3. Inventory Audit

An inventory audit is a cross-examination of inventory records and financial records or statements to ensure that these records are in conformation with the actual count of inventory. The main purpose of an inventory audit is to ensure that the value of stocks of the company is shown in the financial statements and balance sheet. 

There are various methods of inventory audit. The most popular methods are ABC analysis, Cut-Off analysis, Analytical procedure, Freight cost analysis, Finished goods cost analysis, Overhead analysis, Matching, and Reconciliation.

4. Compliance Audit

The compliance audit is done to ensure consistency in the follow-up of rules and regulations made for each department of the company. Under this audit, the auditors do proper examinations of all records of the company to ensure compliance with all the internal and statutory rules and regulations made for the preparation of financial statements, the safety of workers and employees and the quality of products.  Hence, Compliance Audit is one of the most important branches of audit.

5. First, second, and third-party quality audit

a) First-Party Audit 

The first-party audit is generally done by the organization (or an office inside the organization). This quality review is a review of those pieces of the program which is “kept up in its immediate control and inside its hierarchical structure.” (ANSI/ASQC NQA-1 (1986)) Usually, the main party review is directed by the extraordinary review gathering.  

Nonetheless, workers inside the office can likewise assess equivalent to before the party audit. In such a precedent, this “review” is normally known as “self-assessment”. The objective of self-evaluation is to monitor and analyze major intra-dayartal processes, which, if unattainable, have the potential to negatively affect product quality, security, and overall system integrity on a decline and negatively.  

These monitoring and responsibilities are directly analyzed with those most affected by departmental procedures – employees were assigned to the respective departments under the examination. Though the term first-party audit is subjective, the rating suggestions help to improve the entire rating accuracy. If performed properly, first-party audit and self-assessment:

Respond to management that the quality system is effective; · To maintain that endeavour, there are excellent tools to measure returns on investment as well as to meet continuous improvement efforts.


b) Second-Party Audit

The second-party audit is an overall analysis of different authoritative program system which is not under immediate examination or control of the association’s hierarchical system. (ANSI/ASQC NQA-1 (1986)) The second-party review is generally conducted by the customer (or potential providers) to know whether the provider can comply with the current or proposed legally binding requirements.  

The provider quality system is a prime piece of the authoritative requirements because it is directly in charge of the plan, (generation producing, building, acquiring, quality control) and in an indirect way (advertising, inside, and outside deals).  

Nonstop and Control assist the capacity of the goods. Although the analysis of other parties is generally conducted by customers on their providers, and so it is the base for the customer to keep in touch with a free quality assessor. This activity gives the real picture of decency and reasonableness from the clients.

c) Third-party audit

In comparison to the first and second parties audits, where the auditors are not free, the audit of a third party is objective. It is an unrestricted, external auditor or analysis of quality systems taken up by the auditors.  

When complying with the international quality standard (ISO 9000), the “Third Party” is similar to a quality system registrar, bringing up the third-party audit, whose fundamental responsibility is to analyse and continue the quality system by that standard to issue a Conformity certificate (after completion of a successful analysis). 

An internal quality system audit is an examination of this type of audit tool that is used to measure quality. An internal quality audit wants to evaluate an organization’s electronic quality management system (EQMS).

6. Supplier audit

It permits an organization to coordinate with the suppliers directly (in real-time). By auditing the supply chain, companies can control the quality of their suppliers and sub-level suppliers and can introduce accountability for those who perform poorly.  

Key Performance Indicators (KPIs) identify areas for improvement. Due to such an extent of transparency, the supplier can watch transactions like inspection history and receipts to take corrective measures.

7. Audit of the production team

The production team members generally get an exam when the acceptance of auditors or operator’s certification program is in place, or when skill management is essential for eligibility again.  Auditors’ analysis inspections are done by the product which is approved by the operator as part of the alterations in process, past activity for migrations,   re-qualification, evidence of training, and non-contact.

8. Security audit

security audit looks at the plans and procedures created to protect the company’s employees. To ensure regular operation in this type of audit, there may be a review of equipment handling or an examination of organizational procedures. Successful security policies prevent injuries and accidents and improve overall employee welfare.

9. Facilities audit

A facility audit reveals the quality concerns of the corporation’s assets. The components of audit features may include a review of building systems such as HVAC, construction equipment, or technology. A timely review of these facilities is done to make sure that how much quality results are affected by identified improvements.

10. Environmental audit

With an action plan to meet environmental audits and OSHA standards, companies are designed to create a safe working environment by helping identify areas of workplace risk. An audit is conducted to ensure that the employees are following the regulatory standards and operating the right personal protective equipment.

11. Risk assessment  quality audit

A risk assessment is a process that identifies potential workplace hazards and then classifies each risk so that preventive measures can be taken. Such an audit helps companies to form an effective risk mitigation strategy in action. When all risks have been identified, preventive measures can be taken to prevent any kind of happening.

12. Design control audit

Design control audits are organized within highly regulated industries to ensure that the manufacturers follow a formal process, resulting in a product that meets acceptable quality and safety standards. The user needs adequate form Counts from the Design plan and design input, the output is reviewed for proper acceptance criteria, and risk analysis is done.

13. Regulatory audit

Regulatory audits are done to confirm compliance with a particular set of rules or standards. Quality practices are an investigation and a systematic review of the data collection process which is done to identify potential areas of non-conformity and thereafter compliance thereof.

14. Law verification audit

A law verification audit is used by the FDA or other regulatory authorities to ensure that the analytical testing methods used in the manufacturing process are standardized, reproducible, and documentary.  

This method is applied for testing what stability and accuracy are required, usually in cases of products manufactured for human use. 

An Electronic Quality Management System (EQMS) is important in helping a company create an effective audit management strategy.  The system provides flexibility to manage customer-specific audit processes.  

To Sum Up 

Internal Quality Audit is a continuous process of a quality audit by the internal quality audit trained staff or by hiring qualified quality auditors. This is the best way to keep control of the improvement of policies and procedures adopted by the management.  

A quality audit is a deep examination of the quality management system (QMS) of an organization.   This is conducted by specific quality auditors. The main component of quality system standards is ISO 9001.  A quality audit in itself is a separate form of a financial audit.

The primary purpose of a financial audit is to verify the integrity and accuracy of the accounting methods used within the organization. The quality audit is not less important than any other type of audit financial audit, tax audit, performance audit, regulatory audit, and system audit.  

The quality auditors mainly concentrate on the improvement of the quality of the products and management system which includes policies and procedures. A quality audit is very important for any kind of company whether a manufacturing company, trading company, or any other kind of organization. There are various types of quality audits viz. procedure audit, operational audit, items audit, compliance audit, and more.

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