Support Unit for Quality Management

Transcription

1 Unit Leader Hisao MOTEGI Introduction The was established in February, 2007 for the maintenance and management of the quality of work concerning the collection, preservation and distribution of biological resources; it also provides support for techniques used in such work. ISO stands for an internationally uniform standard promulgated by the International Organization for Standardization, and ISO9001 is a standard for Quality Management System. Obtaining the ISO9001 certification endorses that RIKEN BRC is an organization with high reliability, thus ensuring that cells and microorganisms to be distributed from RIKEN BRC meet certain quality standards. To improve the reliability of RIKEN BRC and promote wider utilization of biological resources for research and development purposes by improving the quality of biological resources distributed by RIKEN BRC, the Support Unit leads and takes all possible measures to ensure the QMS s continuing suitability, adequacy and effectiveness. QMS stands for Quality Management System. Activities ISO certification and its maintenance Document management, and preparation of Quality Manual and common BRC Procedure Documents on ISO Record keeping on ISO Planning and implementation of common BRC trainings on ISO Secretariat of Internal Audit Secretariat of Management Review Support for Corrective Action and Preventive Action Support for Quality Control Continual improvement of Quality Management System Members Unit leader Tsutomu KUBOTA (2007.2~2008.3) Hisao MOTEGI (2008.4~) (2007.6~ Chief) [Dotted line members] Senior Research Scientist Motofumi SUZUKI (2007.6~) Masako TAKASHIMA (2007.6~) Technical staff Ⅱ Emi IIMURA (2007.6~) Kanae KURITA (2007.6~) Ayae IHARA (2007.6~) Agency Staff Satoko TSUZUKI (2007.6~) Kanako ISHIKAWA (2007.6~) Koji SASAKI (2007.6~) Sumiko AKIMOTO (2007.6~2008.3) 95

2 Suzuki, Tsuzuki, Akimoto, Ihara, Kurita, Ishikawa Sasaki, Motegi, Yamada(Consultant), Kubota, Iimura, Takashima Specific Aims 1. ISO9001 certification Cells and microorganisms as biological resources are widely used in basic to applied research studies, and have high demands particularly in the field of translational research. In this field, high-quality biological resources are needed, since the deterioration and dispersion of quality affect the accuracy of experiments and the reliability of papers using such data. Thus, two of RIKEN BRC s divisions, namely, the Cell Engineering and Microbe /Japan Collection of Microorganisms, supplying many biological resources to the industrial world, have applied for the certification of ISO9001 from the Bureau Veritas Japan Co., Ltd. (hereafter referred to as BVJC), and received it in August, 2007 (see Figure1). The press release on the receipt of the ISO9001 certification was conducted on August 29, ORGANIZATION RIKEN BRC CELL ENGINEERING DIVISION, and MICROBE DIVISION / JAPAN COLLECTION OF MICROORGANISMS STANDARDS ISO9001:2000, JIS Q 9001:2000 SCOPE OF SUPPLY COLLECTION, PRESERVATION AND DISTRIBUTION OF BIOLOGICAL RESOURCES INDUSTRIAL CLASSIFICATION 38. MEDICAL TREATMENT AND SOCIAL WORK EXPIRATION DATE July 19, 2010 (Certificate number ) RECOGNITION AUTHORITY Bureau Veritas Japan Co., Ltd. BVJC Figure 1. Scope of ISO certification with LOGO mark 96

3 Incidentally, the results of the ISO Certification Audit are good as listed below (see Table 1). QM Document Audit: nonconformity score, 0 Preliminary Audit: nonconformity score, 0 Main Audit: minor nonconformity score, 2 We immediately conducted proper corrective actions against the minor nonconformities and filed corrective action reports to BVJC. As a result, we succeeded in receiving the ISO certification without any follow-up visit by BVJC. Table 1. Summary of ISO9001 certification audit by Bureau Veritas Japan Co., Ltd. Type of audit Date BVJC auditor Location Conclusion and findings QM document audit May 11-25, 2007 Ms. Kazue ITO BVJC The number of nonconformities raised is zero. Preliminary audit June 12, 2007 Ms. Kazue ITO Main audits including field ones July 18, 2007 July 19, 2007 July 20, 2007 Ms. Kazue ITO Mr. Katsuo ONODERA TSUKUBA campus The number of nonconformities raised is zero. TSUKUBA Confirmed that BRC QMS complied with campus ISO and was also driven following ISO TSUKUBA requirements. campus Completed the certification in correcting the WAKO campus two minor nonconformities raised. 2. Design of BRC Quality Management System The Quality Management System is organized as follows (see Fig. 2). Top management: Director of BRC and audit manager: Deputy Director of BRC Middle managements: Head of Cell Engineering and Head of Microbe Mr. Tsutomu KUBOTA, the previous Deputy Director of BRC, worked as and audit manager on ISO from February, 2007 through March 31, He retired from RIKEN on March 31, Dr. Kuniya ABE, current Deputy Director of BRC, was appointed to the vacated position on April 1, Control of documents and quality record keeping Table 2 shows the preparation status of documents and quality Records. In addition, Table 3 shows the history of the Quality Manual, which is the most important document of all QMS documents. Table 2. Preparation of documents and quality records Hierarchy Document/Record Number of items Remark Class 1 Quality manual (QM) 1 (Also needed RIKEN approval) Class 2 Class 3 Class 4 Procedure documents (BRC or each division) Standard operation procedure documents (SOPs) Quality record BRC 7 Six documents required by ISO: including documents control, Cell Engineering 17 Microbe 17 Cell Engineering 34 Microbe 60 BRC 11 Cell Engineering 71 Microbe 26 quality record keeping, internal audit, nonconformity product control, corrective action and preventive action + documents needed by this organization Documents needed by this organization Records required by ISO records needed by this organization Total 244 Details (documents: 136, quality records:108) 97

4 Figure 2. Quality Management System Table 3. History of updating the Quality Manual Version Major reason for updating Issue date 1 Newly created. February 23, Considered the findings of the internal review (April, 2007) and 1st Internal Audit. Considered the findings of the ISO Certification Audit and internal review, and reflected the change in the quality policy. Considered the change in the Tsukuba Institute organization and the findings of the internal review (April, 2008). May 10, 2007 October 19, 2007 May 22,

5 4. ISO common education Table 4 shows the summary of ISO common education in BRC. Table 4. Summary of ISO common education executed in BRC (as of April 1, 2008) Course of Education Location executed Number of participants ISO Introduction Education Internal 63 ISO Normal Education External 9 ISO9000 Internal Auditor External or Internal 38 ISO9000 Certification Auditor External 3 ISO9000 Top Management Education External 6 Total 119 Figure 3. View of ISO9001 common education in BRC 5. Internal Audits Table 5 lists the internal audits that have been executed in BRC QMS thus far. Table 5. List of internal audits executed Sequence number (Timing planned) 1st (before ISO Certification Audit) 2nd (before 1st ISO Surveillance Audit) 3rd (before 2nd ISO Surveillance Audit) Plan tracking # Date executed Department audited Audit team leader Number of nonconformities raised Number of Opportunities for Improvement 1 May 11, 2007 Director of BRC Dr. Yoshimi BENNO April 20, 2007 and Support Unit raised Ms. Kaoru SAIJO April 20, 2007 Cell Engineering Dr. Masako TAKASHIMA April 24, 2007 Microbe Ms. Emi IIMURA November 8, 2007 Director of BRC Dr. Yukio NAKAMURA November 6, 2007 and Support Unit Dr. Yoshimi BENNO November 7, 2007 Cell Engineering Dr. Motofumi SUZUKI November 12, 2007 Microbe Dr. Kaoru FUKAMI June 20, 2008 Director of BRC Dr.Yukio NAKAMURA June 4, 2007 and Support Unit Dr. Takashi HIROYAMA May 29, 2008 Cell Engineering Dr. Takashi ITO May 30, 2008 Microbe Dr. Kazuhiro SUDO Management Reviews Table 6 lists the management reviews that have been executed in BRC QMS thus far. We have strongly promoted the continual improvement of BRC QMS by executing these management reviews appropriately. Table 6. List of management reviews executed Sequence number 1st 2nd 3rd Timing planned Date executed Main participants After 1st Internal Audit, and before ISO Certification Audit After 2nd Internal Audit, and before 1st ISO Surveillance Audit After 3rd Internal Audit, and before 2nd ISO Surveillance Audit May 21, 2007 December 18, 2007 June 27, 2008 Dr. Yuichi OBATA, Mr. Tsutomu KUBOTA, Dr. Yukio NAKAMURA, Dr. Yoshimi BENNO Dr. Yuichi OBATA, Mr. Tsutomu KUBOTA, Dr. Yukio NAKAMURA, Dr. Yoshimi BENNO Dr. Yuichi OBATA, Dr. Kuniya ABE, Dr. Yukio NAKAMURA, Dr. Yoshimi BENNO 99

6 7. Support for Quality Control We have just started a feasibility study of introducing the use of Statistical Quality Control software. 8. ISO9001 Surveillance Audits The 1st and 2nd ISO Surveillance Audits were conducted by BVJC as scheduled. In conclusion, we continue to maintain our ISO certification (see Table 7). Table 7. List of ISO9001 Surveillance Audits executed Surveillance Audit Date Auditor 1st January 8, 2008 Mr. Tomoaki MIZUSHIMA (Lead Auditor of BVJC) 2nd July 18, 2008 Ms. Kazue ITO (Lead Auditor of BVJC) Department audited Director of BRC (Deputy director of BRC) Cell Engineering Microbe Same as above Conclusion and finding Although BRC QMS is still young, it is supported well by all the members and is implemented completely. No nonconformity was found in this audit. Thus, it is concluded that BRC QMS is suitably maintained. No nonconformity finding was found in this audit. BRC QMS is effectively functioning in achieving the objectives of the organization. Thus, continuous maintenance of the ISO9001 certification was concluded. 100