Quality Audit

What is a quality audit

Quality system audit, is to confirm the effectiveness of the implementation of the elements of the supplier's quality system in accordance with the plan to effectively carry out quality activities, whether to achieve the specified quality objectives and inspection and evaluation activities. ysi effective quality management system to help buyers and manufacturers in the production of products to avoid the risks associated with quality problems.

Features of quality audits

1 . Quality audit is one of the means to improve the effectiveness of the quality function of the company. It is a quality activity performed to obtain quality information for quality improvement.

2 . Quality audit is conducted independently, that is, the quality auditor is a person who has no direct interest in the audit object and has the appropriate qualifications or abilities (except for internal audit).

3 . 3. the quality audit is planned according to the prescribed schedule, not unannounced inspection, so the auditors and the audited object of the quality of the personnel responsible for mutual cooperation.

4 . The quality defects or problems found in the quality audit are based on the results of sampling, and the audit report is presented only after a unified understanding with the relevant departments of the audited object, and the quality risks identified are aimed at promoting subsequent quality improvement, controlling and reducing risks.

The basic process of third-party quality audit

1. First meeting

2. Management interview

3. On-site audit (including employee interviews)

4. Document review

5. Summary and confirmation of audit findings

6. Final meeting

1. First meeting.

Participants include auditors and the head of the audit-related department of the supplier, etc. The audit team will introduce the personnel of both parties, the purpose, scope and guidelines of the audit, the schedule, integrity matters, confidentiality matters, and communicate some basic principles and considerations in the audit.

2. Management Interview

The interview includes (1) basic factory information verification (building, personnel, layout, production process flow, outsourcing process); (2) basic management status (management system certification, product certification, etc.); (3) precautions in the audit (protection, accompanying, photo-taking and interview restrictions). Management interviews can sometimes be combined with the initial meeting.

3. On-site audit 5M1E.

After the interview, an on-site audit will be conducted, the length of which is determined by the size of the factory and the complexity of the process. The on-site audit process is generally based on the actual production service process of the factory, usually: incoming material control - raw material warehouse - each processing process - process inspection - assembly and packaging - finished product inspection - finished product warehouse - other special links (chemical warehouse, test room, etc.), mainly on the 5M1E (i.e. the six factors that cause product quality fluctuations, Man, Machine, Material, Method, Measurement, etc.). Method, Measurement, Environment) of the assessment.

On-site audit is the key to the whole factory inspection process, and is the main source of checking and verifying the customer evidence of the actual operation of the factory. This process, the auditor should focus on specific issues, such as raw materials warehouse, the factory is how to do protection, how to manage the shelf life; process inspection, who to check, how to check, how to find problems and so on, and in the checklist to make a record.

4. Documentation audit

Documentation mainly includes documents (information and its carriers) and records (evidence of completion of activities documents), specifically

Documents: quality manuals, procedure documents, inspection specifications / quality plans, operating instructions, test specifications, quality-related regulations, technical documentation (BOM), organizational structure, risk assessment, contingency plans, etc..

Records: supplier assessment records, procurement plan, incoming inspection records (IQC), process inspection records (IPQC), finished product inspection records (FQC), shipping inspection records (OQC), rework and repair records, test records, non-conforming product disposal records, test reports, equipment lists, maintenance plans and records, training plans, customer satisfaction surveys, etc.

5. Summary and confirmation of audit findings

This step is the summary and confirmation of the problems found in the whole audit process, which should be confirmed with the checklist and recorded, mainly recording: problems found in the site audit, problems found in the document audit, problems found in the record inspection, problems found in the cross-check, problems found in the staff interview, problems found in the management interview.

6. Final meeting

Finally, the final meeting is organized to elaborate and explain the findings of the audit process, and sign and seal the audit documents under the joint communication and consultation between the two sides, while reporting on special circumstances.

As a professional third-party inspection organization, Test Library has successfully assisted many buyers and manufacturers to effectively control the key risks in the production process of their products through the implementation of effective quality audits. As a professional third-party auditing organization, typical quality audit services include but are not limited to the following: establishment and implementation of quality management system, supply chain management, incoming material control, process control, finished product control, on-site operation environment and operation method control, risk management, equipment management, personnel competence management, etc.