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1、 QUALITY MANAGEMENT REVIEW管理评审报告Meeting Date : May-15, 2009Time : 2:00PM- 4:30PMVenue : DG office 5B conference roomChairperson : Attendees: MinutesThis management system review covers all XXXXXfunctions, including the Chemical-lab and Microbiological-lab. 1. Review the suitability and effectiveness
2、 of quality system A. External-Assessment Results The external assessments have not been conducted through CNAS until the application documents have been gone through and the laboratory audited by the CNAS auditors. CDLL chemical laboratory has been certified as ISO17025 requirement by SGS-CSTC Stan
3、dards Technical Services Co., Ltd. from Dec-08, 08 to April-29, 09, training program of total 11 days divided to 11 sections including US / EU Standard Methods training, Laboratory staff technical training, ISO-17025 system set up and SOP documents written up, the meeting record referring to CDLL/A-
4、13-02 of 程序文件.B. Internal Audit The internal-audit had been conducted by the CDLL laboratory Manager on April-30, 2009, the report has been summarized the control and set straight of Chemical Lab and Microbiological Lab running system per ISO-17025 criteria. All the correction actions is taking plac
5、e and will be closed the end of May, 09. The audit focus on the following: 1. Corrective action on technical deficiency from staff were not trained and set back full skill on test methods compliance with ISO-17025 to fulfill the applied EU / US testing requirement from CNAS-AL-01-02 shown.2. Complet
6、e the 程序文件CDLL/A-（00-29）records for Chemical and Microbiological laboratory and make sure to continue assess from time being when necessary to keep record. The internal audit内审 was cooperated with SGS auditor, Henter Huang, throughout the above 11 sections set time and the corrective actions had bee
7、n done in time and accept by auditors. The internal audit内审 report is referring to CDLL/A-11-03 of 程序文件CDLL/A-（00-29）.C. Proficiency Test 能力认可and internal Correlation programsProficiency Test (PT): The lab had finished all the 2 rounds PT tests in 2009, including 2 major category EN71 and RoHS requi
8、rement that were organized by CNAS authorized _ organizations. The PT was highlighted and taken corrective action by P-lab. The action report No. is _ with report received on _ and the results were match and pass with their set data from their given samples. External-lab correlation testing (IQC):Th
9、e lab had taken part in a lot of correlation tests including RoHS and 6 Phthalates during 2008-09. The results are satisfied (see the following summary): No.Name of RRTInitiatorEndLab listdescription1CDec 06RSTS Jan. 2007SZ, GZ, SH, total heavy metal content of fabric sample2Cadmium-001Guangzhou Lab
10、Jan. 2007GZ, SZCadmium content in Rubber material. 3CANONJapan labJan. 2007SZ, GZ, HK, Pb/Ni+P in plating on Ni/SPCC sample4Inter-lab correlation exercise Jan 2007 - SoftlineRSTS HKMar,2007Phthalates & Azo dyes test in standard solution and samples 5SGS-BFR-PAT-011 RSTS TWApr.,2007PBBs&PBDEs in stan
11、dard solution and samples6SGS-HM-PAT-012 (RoHS) / SGS-ELV-PAT-001 (ELV) RSTS E&E May, ,2007Heavy metal testing7Nintendo Round Robin Test Japan labJun. 2007phthalates content in pellet & powder by Nintendo method8EE/HL/SL 0708RSTSAug,2007phthalates9RRTP-0701Nov.2007Heavy metals (Pb, Cd, Hg, Cr)PBBs &
12、 PBDEsRoHS 6 items10Physical & Mechanical, Flammability Test SH-HGNov 2007HG,HKASTM F963-07,Canada Crc.931BS7272-1,2Internal Comparison Test from Technicians Comparison tests were completed and continue monthly according to the record on _ throughout year 2009 May. The reference standard _ were used
13、 as a correlation subject to be tested by 3 technicians in laboratory.D. Complaints & feedback from customers: In _ 2009, there was one complaint received from the client xxxx. The case was on that the laboratory report, which cannot meet with the clients requirement and the record is filed on CDLL/
14、A-06-01.Our laboratory executive has taken relevant immediate corrective actions and the client end up accepted correction. To meet with our inner management requirement, corrective action was verified further through customer satisfactory survey which referring to the record on CDLL/A-06-02客户抱怨登记表a
15、nd CDLL/A-23-01报告更改/补发申请表E. Corrective and preventive actions initiatedThe lab can taken corrective action for SGS raised external & internal audit, clients complaint / claim and unsatisfied results coming from comparison test in time. The individual 程序文件 regarding to preventive actions had been iss
16、ued, and the preventive action plan need to be made in next lab meeting by 31st, May 2009.F. Inner Quality monitor resultsAll the lab quality monitors have been assigned and trained. The physical-lab and electrical-lab have issued the Inner Quality monitoring schedule and the relevant monitoring hav
17、e been implemented according to the LQP021 in Jan 2008. But the chemical lab and C/S havent made the Inner Quality monitoring schedule, need to be followed up by early, 2008.2. Review current lab capacities and resources for future development/ New technology or equipment The lab shall applied for C
18、MA accreditation for company future business development requirement. The lab technical colleagues title of relative professional engineer (English, computer exam, paper writing) should be followed up.3. Others:H. Training The quality system training shall be specified and strengthened with individu
19、al quality procedure implement to lab staff. The documents written method and the complaint /claim case etc. shall be trained in toys requirement. For the staff turnover rate is high, the new staff should be trained in technical in time. By 2010 year, the laboratory will increase headcount to 10 per
20、sons in total. Training program will be arranged the end of 2009 for the new staff and continuing education to old staffs. From time to time seminar hold by the third party that our staff are arranged to join for nourishing their technical knowledge.I. Household and safety: The safety training cours
21、e for all lab staffs was conducted by QA coordinator in Feb 2007. The lab safety audit works were conducted by SGS global QA manager in June and by Shenzhen QA in Sep 2007 respectively. The Shenzhen HR and QA jointly checked the lab safety works in Nov 2007.4. Output / Improvement.Followed up: Items
22、Action description Followed by Completed dateRemarkCorrective action for HOKLASThe customer satisfaction survey implemented according to LQP024 including response of phone etc.At early of March 2008Overall objectives &KPISome KPIs and objectives need to be redefined in 2008.At the end of Mar2008Prev
23、entive action Preventive action plan items raised At the end of Mar2008Training Document write e.g. SOP, WI and Claim/complaint case training courses shall be held.July 2008Quality monitor The C-lab and C/S department inner Quality monitor schedule shall be madeAt the early of Mar 2008CMA accreditat
24、ion lab technical colleagues title of relative professional engineer (English, computer exam, paper writing) should be followed upBy Aug 2008Standard purchase The support for standard purchase shall be strengthened, the stand-in shall be assigned.t By March 2008Prepared by: Reviewed by: Annex: Summa
25、ry of action required internal audit by Shenzhen QA in 2007SubjectNon-complianceCAR-NO. Personnel SZ0709-A01EquipmentSZ0709-A02Report results controlSZ0709-A03Personnel SZ0709-A04Sample handling SZ0709-A05Method confirmation SZ0709-A06Method confirmationSZ0709-A07Safety ISZ0709-A08Traceability SZ0709-A095of 6