Types of Quality Audits

What is an Audit?

→ As per the ISO 19011:2018 Standard (Guidelines for auditing management system),

→ "An audit is a Systematic, Independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled."

→ The_audit evidence includes Records, Statements of fact, or other information which are relevant and verifiable.

→ The_audit criteria include a set of policies, procedures, or requirements.

→ In easy language we can say that the_audit is on-site verification activity, such as inspection or examination, of a process or quality management system, to ensure compliance to requirements.

→ In other words, we can say that the_audit is to check the health of the system.


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Types of Quality Audit

→ There are three main types of audits as per the Quality Management System that is mentioned below.

  1. Process Audit
  2. Product Audit
  3. System Audit

→ Apart from the above three audits, there are some more audits that are followed by the organization like, pre-dispatch audit, dock audit, layout audit, 5S audit, layer audit, but all are part of any one of the above three audits.

Three Types of audit in QMS

1. Process Audit:

→ Process_audit verifies that the processes are carried as per the defined or not?

→ It verifies the actual method of working against the defined instructions and sets of standards.

→ We can also say that the process_audit verifies and ensure the overall process of the operations.

→ It covers all processes in between order receives to order delivery and post-delivery activities.

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2. Product Audit:

→ Product_audit verifies the product or service again the defined standards.

→ In the case of the product, we can refer to the product drawings and customer-specific requirements.

→ In service_audit, we can refer to the contract agreement or blueprint document that we have made during the order confirmation.


3. System Audit:

→ A system audit is an audit of the management system that is implemented in the organization.

→ In other words, we can say that the system_audit is used to check the health of the system.

→ There are too many systems available like Quality Management System (ISO 9001), Automotive Quality Management System (IATF 16949), Environment Management System (ISO 14001),  Occupational Health and Safety Management System (ISO 45001), likewise...

→ As per the requirement of an organization, they implement the system and check against the standard clauses of the particular management system, whether it conforms to the specification or not?


What are Internal and External Audits?

→ An audit may also be classified as internal or external, depending on the interrelationships among participants.

→ Internal audits are performed by employees of the organization.

→ External audits are performed by an outside agent.

→ Internal audits are often referred to as First-party audits, while external audits can be either Second-party and or Third-party.

Types of audits in QMS

What are First Party, Second Party, and Third-Party Audits?

First Party Audit:

→ A first-party audit is performed by the employee of the organization and it is performed within the organization.

→ We can also say it as an internal audit.

→ In this audit, the auditor verifies the processes against the standard that is implemented by the organization.


Second-Party Audit:

→ A second-party audit is performed by a customer or by a contracted organization on behalf of a customer.

→ We can say it is a customer_audit and it is a type of external_audit.

→ This audit is very important for the organization because the audit findings directly impact the business of the organization.


Third-Party Audit:

→ A third-party audit is performed by an audit organization.

→ It is also known as a certification body.

→ The third-party_audit is an independent audit_body and it is free from any conflict of interest.

→ We can arrange third-party audits for various activities like certification, recognition, an award, license approval, claim survey of insurance, etc.


What is the audit process?

→ The four steps of an audit process are mentioned below.

  1. Audit planning and preparation
  2. Audit execution
  3. Audit reporting
  4. Audit follow-up and closure
Four Steps of Quality audit

1. Audit planning and preparation:

→ The first step is planning and preparation for the audit.

→ In this stage, the auditor, the lead auditor, and the auditee need to prepare for the audit, and the audit objective must be in inline with the organization's objective.


2. Audit execution:

→ The second step is called audit execution or we can also say that the fieldwork.

→ The data collection is done in this phase of the audit.

→ Audit execution includes many activities like on-site audit, meeting with the auditee, understanding the process and system controls and verifying that these controls work, communicating among team members, and communicating with the auditee.


3. Audit reporting:

→ The third step is audit reporting.

→ The audit report is communicated with the organization in this phase.

→ It includes the investigation and findings during an audit.

→ The audit report should be clear, easy to understand, and effective for the management to take necessary action.


4. Audit follow-up and closure:

→ The last step is audit follow-up and closure.

→ According to ISO 19011, "The audit is completed when all the planned audit activities have been carried out, or otherwise agreed with the audit client."

→ Also, as per ISO 19011, the verification of follow-up actions may be part of a subsequent audit.

What is the audit process

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6 Comments

  1. If a major non conformity is found during the audit, should the QMS Auditor stop production, inform the quality management team as soon as practicable or call a meeting with auditor

    ReplyDelete
    Replies
    1. Auditor is the assessor of the QMS system. As per the QMS who has the authority for production stoppages those can stop the line.

      Delete
  2. What is the different between audit and auditee?

    ReplyDelete
    Replies
    1. The auditor is the person performing the audit and the auditee is the organization and people being audited are together called the auditee

      Delete
  3. Dear sir Kindly share process audit check list

    ReplyDelete
    Replies
    1. You can join our LinkedIn page we have already shared all tutorial over there. Thanks!!!

      Delete

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