Quality Audit

1. Quality audit is one of the means to improve the effectiveness of the enterprise's quality function. It is a quality activity carried out to obtain quality information for quality improvement;

2. The quality audit is conducted independently, that is, the quality auditor is a person who has no direct interest relationship with the audit object and has the corresponding qualifications or capabilities;

3. Quality audits are planned and conducted according to a prescribed schedule, not surprise inspections, so the auditors and the quality responsible personnel of the audited object cooperate with each other;

4. The quality defects or problems found in the quality audit are based on the results of sampling. The audit report is submitted only after reaching a consensus with the relevant departments of the audited object. The purpose of identifying quality risks is to promote subsequent quality improvements, control and reduce risks.

1. First meeting:

Participants include auditors and heads of audit-related departments of suppliers. The audit team will introduce the personnel of both parties, the audit purpose, scope, criteria, schedule, integrity matters, confidentiality matters, and communicate some basic principles and precautions in the audit.

2. Management interviews

The interview content includes (1) verification of basic factory information (buildings, personnel, layout, production process, outsourced processes); (2) basic management status (management system certification, product certification, etc.); (3) matters needing attention during the audit (protection, accompaniment, photography 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, and the duration will be 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: feed control-raw material warehouse-various processing procedures-process inspection-assembly and packaging-finished product inspection-finished product warehouse-other special links (chemical warehouse, test room, etc.), mainly for the assessment of 5M1E (i.e., the 6 factors that cause product quality fluctuations, Man, Machine, Material, Method, Measurement, Environment).

On-site audit is the key to the entire factory inspection process and is the main source of customer evidence for checking and verifying the actual operation of the factory. In this process, auditors should pay attention to specific issues, such as how the factory protects the raw material warehouse and how to manage the shelf life; in process inspection, who will inspect, how to inspect, what to do if problems are found, etc., and keep records in the inspection form.

4. Document review

Documents mainly include documents (information and its carrier) and records (documents of evidence of completed activities), including:

Documents: quality manual, procedure documents, inspection specifications/quality plans, work instructions, test specifications, quality-related regulations, technical documents (BOM), organizational structure, risk assessment, emergency plans, etc.;

Records: supplier assessment records, procurement plans, incoming material inspection records (IQC), in-process inspection records (IPQC), finished product inspection records (FQC), outgoing 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 a summary and confirmation of the problems found during the entire audit process. They need to be confirmed with the checklist and recorded. The main records include: problems found in the on-site audit, problems found in the document review, problems found in the record check, problems found in the cross-check, problems found in employee interviews, and problems found in management interviews.

6. Final meeting

Finally, a final meeting is organized to explain the findings during the audit process, and the audit documents are signed and sealed after mutual communication and consultation, and special circumstances are reported.