Factory Audits & Quality Inspections During & Post COVID-19: On-site Supplier Audits + Remote Participations by International Buyers (IV) (Continued from the last issue)
Audit scope Audit scope refers to the scopes of a specific audit area, function, process and product. Generally, the quality management system audit should cover all the processes and functions of suppliers; Process audit mainly focuses on process characteristics, control capability of important processes and processes related to customer products; Product audit mainly focus on the characteristic control of the purchased products; When It is found that the supplier's performance is weak during the audit, it is necessary to audit the projects or processes with poor performance. For example, if the supplier always delays delivery, an audit should be conducted on the delivery process, including the supplier's quality performance evaluation index (delivery timeliness), production plan completion rate, etc. Auditor selection Qualified auditors are required to have national CCAA registered ISO9001:2015 qualifications, also pass the IATF16949:2016 training examinations by professional institutions, fully understand the product production process, and familiar with the five major tools (PPAP, FMEA, SPC, MSA). Then based on the scope of the audit, auditors who meet the professional requirements are selected to participate in the audit. Generally, the skills of auditors can be determined by their qualification, education level, work experience and audit experiences. For suppliers with high customer requirements, strong safety-related products and high importance, the audit team members can be organized into multi-functional teams, which can conduct a comprehensive and in-depth audit on suppliers.
▌Audit checklist
compilation and audit completion
Audit checklist is compiled by the auditors. For different types of audits, the audit checklist is different. For an IATF16949 2nd party audit, the checklist will be based on the IATF16949:2016 standard, covering the audited party's quality manual, procedure documents, operational documents and related records, relevant national, industry or local laws and regulations,etc. The audit is then performed on each department in turns according to the planned audit checklist and audit records are made. At the end of the audit, the audit team reviews the audit findings, summarizes the items in compliance, and indicate the audited sites, functions, processes or requirements. Each audit finding and its evidence of conformance should be recorded. Nonconformity (NC) and their supporting evidence should also be recorded. NCs shall be classified, fully communicated to the management of the audited party in a timely manner and reviewed by the management representative of the audited party. The audit checklist uses a scoring system to evaluate whether the supplier meets the requirement that "process formed in relation to product quality". The evaluation conclusions can be grouped into the following three cases: The audit is approved and the supplier can be included in the list of qualified suppliers. The nonconformities discovered in the audit need to be rectified, the NCs closed after the submitted evidences are verified, and only then can the supplier be included in the list of qualified suppliers. The audit is rejected.
The system audit report mainly includes: supplier basic information, audit checklist (including scores and grading), NC List, correction plan, factory photos (overview, certifications, main production and testing equipment, sample room, warehouse, main production workshops, laboratory, etc.). Process audit report mainly includes: control plan, compliance audit of control plan, NC list, and correction plans. The process audit is not scored. Product audit report mainly includes: product overall inspections (such as specifications, models, packaging quantity, packaging requirements,label, etc.), sampling plan, sampling number, inspections of quality characteristics (such as: surface treatment, material, appearance defects,etc.), performance testing (such as metallographic structure, tensile strength,heat treatment hardness, coating thickness, etc.), full size inspections, reliability testing (such as RoHS), etc. There is no scoring for product audit.
▌Summarize the audit results after the audit
If it is a QMS audit in the automobile supply chain, we will undertake the audit according to the ITAF16949:2016 standard and the audit plan and checklist prepared by the audit team leader. The audit process needs the cooperation of the company senior management and the audit guide. Process audit will be conducted based on the control plan of the whole production process or a special process, depending on the customer requirement. Sometimes a process or product audit could be undertaken according to VDA6.3 and VDA6.5 standards when requested by customers in some European countries. During the audit, the audit team shall keep communicating with the company management on the audit results and the audit report. The auditee is also required to submit the corrective and preventive plans. And the conclusion of the audit must be summarized.
▌Verify the corrective
effect and close the nonconformities
The second party audit of the supplier is not finished after the audit report is submitted, but only after the NCs discovered on-site are closed after the evidences provided by the supplier are verified. The closing time of NCs depend on the nature of NCs, the difficulty of rectification and the importance the supplier has placed on rectification.
(To be continued) |