What Is a Quality Control Audit?

The quality management system audit is to verify whether the quality activities and related results are in accordance with the organization's planned arrangements, confirm whether the organization's quality management system is correctly and effectively implemented, and whether the requirements in the quality management system are helpful to achieve the organization's quality policy and quality Objectives, identify problems in a timely manner, take corrective and preventive measures, and provide opportunities for improvement of the quality management system for the audited department / personnel of the organization to ensure that the organization's quality management system is continuously improved and improved.

Quality management system audit

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1. Ensure that the organization's quality management system conforms to the requirements of the ISO / TS16949 quality management system;

2. Ensure that the organization follows the documents of the organization's quality management system;

3. Decide whether the results of the organization's quality management system are effective in achieving the quality policy and quality objectives;

4. Supervise the implementation and effectiveness of corrective and preventive measures;

5. Put forward information and opportunities for improvement of the organization's quality management system;

6. Decide whether the organization's quality management system is a series of processes, not just a collection of independent elements.

1. The quality management system standard selected by the organization;

2. Organize the quality manual, procedure files, quality plan, operation instructions and forms / records of the quality management system;

3. Contract / order;

4. Special customer requirements;

5. International / national, government / regional laws, regulations and standards related to organizational products.

The audit method is mainly divided into two parts:

1. Document review: Review whether the quality manual of the organization's quality management system, procedure documents, work instructions, forms / records and other required supporting documents cover the ISO / TS16949 quality management system (technical specification) standards.

2. On-site audit: audit the extent and effectiveness of the organization's quality management system.

1) Each on-site audit, including the initial audit (the first formal audit) and the annual surveillance audit, must include the following aspects and content audits:

a) New customers from the last audit.

b) Customer complaints and organizational response.

c) the results and measures of the organization's internal audit and management review.

d) Progress towards continuous improvement goals.

e) Effectiveness and verification of corrective actions since the last audit.

2) Contains the quality management system of Chapter 4, the management responsibilities of Chapter 5, and the product realization process of Chapter 7.1 to 7.3, which must be audited at least once for each 12-month continuous on-site audit.

From December 14th to 15th, 2010, the branch organized the second internal quality management system audit of the year, and the deputy general manager

1.Initiation of audit

(1) Designated audit team leader

(2) Determine the purpose, scope and criteria of the audit

(3) Determine the feasibility of the audit

Determine the feasibility of the audit and consider the availability of factors such as:

Adequate and appropriate information required for planning an audit;

Full cooperation of the auditee;

sufficient time and resources.

When the audit is not feasible, an alternative proposal shall be made to the audit client after consultation with the auditee.

(4) Select the audit team

(5) Establish preliminary contact with the auditee

Establishing initial contact with the auditee on audit matters may be formal or informal, but should be performed by the person or audit team leader responsible for managing the audit programme. The purpose of the initial contact is to:

Establish communication channels with representatives of the audited parties;

Confirm the authority to conduct the audit;

Provide information on the proposed timing and composition of the review team;

Require access to relevant documents, including records;

Determine applicable site safety rules;

Make arrangements for the review;

Agree on the participation of observers and the needs of the review team guide.

2. Implementation of document review

The auditee's documents should be reviewed prior to the on-site audit activity to determine the compliance of the system described in the document with the audit criteria. In some cases, the documentation review may be postponed until the on-site activity begins, without affecting the effectiveness of the audit implementation. In other cases, in order to obtain a proper understanding of the information available, an on-site visit may be conducted.

If the documents are found to be inappropriate and inadequate, the audit team leader shall notify the audit client and the person responsible for managing the audit programme and the auditee. A decision should be made whether the review should continue or be suspended until issues with the document are resolved.

3. Preparation for site audit

(1) Preparation of audit plan

The audit team leader shall prepare an audit plan.

The audit plan should include:

audit purpose;

Audit criteria and cited documents;

Audit scope, including determining the organizational units and functional units and processes to be audited;

Date and place of on-site audit activities;

The expected time and duration of on-site audit activities, including meetings with the auditee's management and audit team meetings;

The roles and responsibilities of the audit team members and accompanying persons;

Allocate appropriate resources for critical areas of the audit.

Before the on-site audit activities begin, the audit plan shall be reviewed and accepted by the audit client and submitted to the auditee.

Any objections of the audit party shall be resolved between the audit team leader, the auditee and the audit client. Any revised audit plan should seek the consent of all parties before continuing the audit.

(2) Audit team work distribution

The audit team leader shall, in consultation with the audit team, assign audit responsibilities for specific processes, functions, locations, areas or activities to each audit member. The distribution of the work of the audit team should take into account the needs of the auditor's independence and ability, the effective use of resources, and the different roles and responsibilities of auditors, trainee auditors and technical experts. To ensure that the purpose of the audit is achieved, the assigned work can be adjusted as the audit progresses.

(3) Preparation of working documents

Auditing members shall review the information related to the auditing work undertaken by them and prepare necessary working documents for reference and recording of the auditing process. Can include:

Checklist and audit sampling plan;

Forms that record information (for example, supporting evidence, audit findings, and meeting records).

The use of checklists and forms should not limit the content of audit activities, which can change with the results of the information collected during the audit.

Working documents, including records formed after their use, shall be kept at least until the end of the audit. Members of the audit team should keep working documents related to confidential or intellectual property information at all times.

4. Implementation of on-site audit

(1) Hold the first meeting

Hold the first meeting with the auditee's management, or (where appropriate) with the person responsible for the audited function or process. The first meeting should be chaired by the review team leader. The purpose of the first meeting is

Confirm the audit plan:

Briefly introduce how to implement audit activities

confirm communication channels;

Provide the opportunity for questioning to the auditee.

In many cases, such as in an internal audit of a small organization, the first meeting can simply include communication about the upcoming audit and an explanation of the nature of the audit.

For other audits, the meeting should be formal and keep records, including those of attendees.