1. General Requirements (Quality Management Systems) | Initial Audit | Follow-up audit |
Critical |
1.1 | The factory management is willing to improve on any significant areas of concern identified during the audit. | Pass |
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Comment | During the audit, the factory management had a positive attitude on improvement of the NCs. |
Level 3 |
1.2 | The factory has an implemented formal quality policy and/or operates appropriate and traceable QA processes and procedures. |
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Comment | The quality policy and effective practical objectives were documented in the quality manual (QM-01,V:A/0) which was issued on Dec 31, 2015 and implemented in the factory. Also most of the necessary quality procedures such as document control procedure, internal audit procedure, non-compliance product control procedure and etc were established in place. But based on documents review, it was noted that there was no documented finished products inspection specification which included sampling method, inspection items, inspection criterions, acceptable levels, etc, and they were only showed on finished product inspection records. |
1.3 | The factory has an organisational chart, clearly defining responsibilities of key staff. |
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Comment | Formal organization chart and description of position and responsibility were defined clearly in quality manual. Quality functional department was clearly separated from production according to factory organization. |
1.4 | There is a nominated person or manager accountable for raw material and product quality, safety and legality. |
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Comment | Mr. Shi Guangyao was nominatedas QA Manager accountable for quality issues based on documents review. |
1.5 | The Quality Manager has the authority to stop production and/or despatch. |
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Comment | The quality manager had sufficient authority to control quality which was defined in the chapter 5.1 “Working Responsibility and Authority” of quality management manual (QM-01,V:A/0). |
1.6 | All factory workers are adequately trained to carry out their tasks. |
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Comment | The factory clearly defined the policy and procedure for training all staff in their roles and responsibilities in human resource management control procedures. Based on document review, the factory established training plan of 2015 and 2016, and provided relative training according to the plan. |
1.7 | The factory has in-house testing facilities, using calibrated equipment where relevant. |
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Comment | The factory did not have vernier calipers to conduct dimension measurement on materials and products accurately. And the factory using moisture instrument was not calibrated. |
1.8 | The factory has a system in place for maintaining and controlling records that provide evidence of raw material and product quality, safety and legality. |
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Comment | Most related records were maintained by the factory, But the inspection records of some raw materials such as calcium carbonate and MDF boards were not maintained by the factory. |
1.9 | Products are batch coded, allowing traceability to production runs and/or PO numbers. |
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Comment | From onsite observation, the products in the workkshop were identified with product information like: lot/PO number, name, specification, quantity, receipt date. |
1.10 | A system is in place for recording and investigating customer complaints that relate to product quality, safety or legality. |
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Comment | The customer complaint handling procedure was established in place to recording and investigating customer complaints. |
1.11 | A procedure is in place to manage product non-conformance, including the communications and actions required by the customer, inspection bodies and supply chain companies (e.g. external storage, shipping). |
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Comment | The factory established non-conformities control procedure to manage product non-conformance, and related records were provided for review. |
1.12 | Where the factory is based in the European Economic Area (EEA) all substances in the product(s) produced by the factory are registered or pre-registered under the REACH Directive for the appropriate use. |
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Comment | It was not applicable. The factory was based in China. |
1.13 | Where the factory is based in the European Economic Area (EEA) the factory has a plan to phase out any substance which appears on the REACH Candidate List of Substances of Very High Concern. |
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Comment | It was not applicable. The factory was based in China. |
1.14 | Where the factory is based outside of the European Economic Area (EEA) they are aware of the requirements under REACH and they are able to provide accurate Bills of Material for their applicable products. |
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Comment | The factory managements had no knowledge of the requirements of REACH including SVHC and there were no Bills of Materials for their applicable products hold by the factory. |
Level 2 |
1.15 | The quality policy is fully endorsed by senior management and reviewed annually. |
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Comment | The quality policy was endorsed by the general management. |
1.16 | There is evidence that the Quality Manager is competent on the basis of education, training, skills and experience. |
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Comment | Yes, confirmed by document review and management interview. |
1.17 | The factory has implemented a systematic programme for documentation and record control. |
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Comment | The factory did not have controlled document list, and the using documents in place such as woodworking process quality standards, painting process quality standards, polishing process quality stanradrs, etc were not under control. |
1.18 | The factory has implemented an effective system that defines responsibilities, requirements for planning and conducting audits, establishing records and reporting results. |
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Comment | Yes, it was confirmed by document review and management interview. |
1.19 | Audits are carried out at planned intervals to determine whether the QMS and process are appropriate. |
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Comment | Factory had established internal quality audit procedure, which defined internal audit should be conducted once a year. The latest audit was conducted on Apr 18, 2016. Related document was kept in the factory. |
1.20 | There is a documented programme of on-going training and performance reviews for all workers. |
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Comment | The factory clearly defined the policy and procedure for training all staff in their roles and responsibilities in human resource management control procedures. Based on document review, the factory established training plan of 2015 and 2016, and provided relative training according to the plan. |
1.21 | The factory has relevant performance and safety certification for all the products being produced. |
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Comment | Based on documents review and management interview, the factory would get the 3rd laboratory test reports as customer requirement for each type of products before shipment. |