Quality audit features and processes!
Release time:
2023-08-16 14:42
Source:
ISO9000 defines audit (Audit) as follows: audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the degree of compliance with audit criteria.
Therefore, the audit is to find audit evidence, and it is evidence of compliance.
Audit classification
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project |
definition |
Purpose |
|
First Party Audit |
internal auditing within the organization |
Seek internal opportunities for continuous improvement as an important management tool. |
|
Second Party Audit |
QSA (supplier system audit) and QPA (supplier process audit) conducted by customers on suppliers |
Communicate the consensus on quality requirements between the supply and demand sides, and the audit results are usually used as the basis for customer purchase decisions. |
|
third party audit |
An audit of an organization by a third party, i.e. an external audit |
Determine whether the quality management system requirements meet the specified requirements, and finally pass the certification and obtain a report or certificate. |
At present, the main audit types in the industry are:
Social responsibility audit : typical such as Sedex (SMETA); BSCI
质量审核:典型如 FQA;FCCA
反恐审核:典型如SCAN;GSV
环境管理审核:典型如FEM
其他客户定制化审核:如Disney人权审核,Kmart利器审核,L&F RoHS审核,Target CMA审核(Claim Material Assessment)等。
审核又叫验厂,很多客户希望供应商在质量、社会责任(人权)、反恐等方面的管理体系达到一定的要求,因此在下订单之前会自己或委托第三方公证行检查工厂状况,在确认工厂没有严重问题存在后,才能够将工厂纳入合格供应商名单,才会下订单并长期合作。
质量审核的类别
质量审核是企业为确定质量活动和有关结果是否符合计划安排,以及这些安排是否得到了有效的实施、能否达到预定的目标而做的系统的、独立的检查和审查。质量审核,根据审核的对象,又可分为以下3种:
1.产品质量审核。指对准备交给用户使用的产品的适用性进行审核;
2.工序质量审核。指对工序质量控制的有效性进行审核;
3.质量体系审核。指对企业为达到质量目标所进行的全部质量活动的有效性进行审核。
质量审核的特点
1 . 质量审核是提高企业质量职能有效性的手段之一。它是为获得质量信息以便进行质量改进而过行的质量活动;
2 . 质量审核是独立进行的,即质量审核人员是由与审核对象无直接利益关系并有相应资质或者能力的人员(内部审核除外);
3 . 质量审核是有计划按规定日程进行的,不是突击检查,因此审核人员与被审核对象的质量责任人员的相互合作的;
4 . 质量审核中发现的质量缺陷或问题,是基于抽样的结果,在与被审核对象有关部门统一认识后才提出审核报告的,识别出的质量风险目的是为了促进后续的质量改进,控制和降低风险。
第三方质量审核的基本流程
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1.首次会议
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2.管理层访谈
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3.现场审核(包括员工访谈)
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4.文件资料审核
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5.审核发现汇总和确认
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6.末次会议
1.首次会议:
参加人员包括审核人员和供应商的审核相关部门的负责人等,审核团队会介绍双方人员、审核目的、范围、准则,日程安排,廉政事项、保密事项,并沟通审核中的一些基本原则和注意事项。
2.管理层访谈
The interview content includes (1) verification of basic factory information (architecture, personnel, layout, production process flow, outsourced processes); (2) Basic management status (management system certification, product certification, etc.); (3) Precautions during the audit (protection, accompanying, photography, and interview restrictions). Management interviews can sometimes be combined with the first meeting.
3. On site audit 5M1E:
After the interview, an on-site audit will be conducted, and the duration will be determined based on the size of the factory and the complexity of the process. The on-site audit process is generally based on the actual production and service process of the factory, usually including: incoming control - raw material warehouse - various processing processes - process inspection - assembly packaging - finished product inspection - finished product warehouse - other special links (chemical warehouse, testing room, etc.), mainly assessing 5M1E (i.e. the six factors that cause product quality fluctuations, such as human, machine, material, method, measurement, and environmental environment).
On site audit is the key to the entire factory inspection process and 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 manages the shelf life; During the process inspection, who will inspect, how to inspect, and what to do if problems are found, etc., and make records in the inspection form.
4. Document review
Documents mainly include documents (information and its carriers) and records (evidence documents for completing activities), specifically:
Documents: quality manual, procedural documents, inspection specifications/quality plans, work instructions, testing specifications, quality related regulations, technical documents (BOM), organizational structure, risk assessment, emergency plans, etc;
Records: Supplier evaluation records, procurement plans, incoming inspection records (IQC), process inspection records (IPQC), finished product inspection records (FQC), outgoing inspection records (OQC), rework and repair records, testing records, non-conforming product disposal records, testing reports, equipment lists, maintenance plans and records, training plans, customer satisfaction surveys, etc.
5.审核发现汇总和确认
This step is to summarize and confirm the problems found in the whole audit process, which need to be confirmed with the checklist and recorded. The main records are: problems found in on-site audit, problems found in document review, problems found in record inspection, and cross-check findings problems, problems found in employee interviews, and problems found in managerial interviews.
6. Closing meeting
Finally, organize the final meeting to elaborate and explain the findings during the audit process, sign and seal the audit documents under the joint communication and consultation of both parties, and report special circumstances at the same time.
Products are the fruit, and quality management capabilities are the cause. Only when the factory establishes and implements an effective quality management system can it guarantee the ability to produce products that meet the standards in a stable and continuous manner. The inspection of the results of the product is the inspection. The inspection of the quality assurance ability in product production is the inspection of the cause, which is the quality audit.
As a professional third-party inspection agency, EC inspection has successfully assisted many buyers and manufacturers to effectively control the key risks in the production process of products by implementing effective quality audits. As a professional third-party auditing organization, typical database quality auditing services include but 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 operating environment and operating methods Control, risk management, equipment management, personnel capacity management, etc.