Support Unit for Quality Management

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Unit Leader

Support Unit for Quality Management

Introduction

Activities

The Support Unit for Quality Management 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 Organizat ion for

Standardization, and ISO9001 is a standard for Quality

Management System. Obtaining the ISO9001 certification

endorses that RIKEN BRC is an organization with high

● 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

MembersUnit leader

Tsutomu KUBOTA (2007.2~2008.3) Hisao MOTEGI (2008.4~) (2007.6~2008.3 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)

Hisao MOTEGI

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.

● 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

Support Unit for Quality ManagementRIKEN BRC Annual Report 2005 ～ 2007

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Suzuki, Tsuzuki, Akimoto, Ihara, Kurita, IshikawaSasaki, 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 Division and Microbe Division/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, 2007.

Figure 1. Scope of ISO certification with LOGO mark

■ 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：378358)

■ RECOGNITION AUTHORITY： Bureau Veritas Japan Co., Ltd.（BVJC）


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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 ITOTSUKUBA

campusThe number of nonconformities raised is zero.

Main audits including field ones

July 18, 2007

Ms. Kazue ITOMr. Katsuo ONODERA

TSUKUBA campus

Confirmed that BRC QMS complied with ISO and was also driven following ISO requirements. Completed the certification in correcting the two minor nonconformities raised.

July 19, 2007TSUKUBA

campus

July 20, 2007 WAKO campus

2. Design of BRC Quality Management System

The Quality Management System is organized as follows (see

Fig. 2).

Top management: Director of BRC

Management representative and audit manager:

Deputy Director of BRC

Middle managements: Head of Cell Engineering

Division

and Head of Microbe Division

Mr. Tsutomu KUBOTA, the previous Deputy Director of

BRC, worked as “Management representative and audit

3. 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.

manager on ISO” from February, 2007 through March 31,

2008. He retired from RIKEN on March 31, 2008. Dr. Kuniya

ABE, current Deputy Director of BRC, was appointed to the

vacated position on April 1, 2008.

Hierarchy Document/Record Number of items Remark

Class 1 Quality manual (QM) 1 (Also needed RIKEN approval)

Class 2Procedure documents

(BRC or each division)

BRC 7 Six documents required by ISO: including documents control, quality record keeping, internal audit, nonconformity product control, corrective action and preventive action + documents needed by this organization

Cell Engineering Division

17

Microbe Division 17

Class 3Standard operation procedure

documents (SOPs)


34Documents needed by this organization

Microbe Division 60

Class 4 Quality record

BRC 11Records required by ISO9001 + records needed by this organization


71

Microbe Division 26

Total 244 Details (documents: 136, quality records:108)

Table 2. Preparation of documents and quality records


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Figure 2. Quality Management System

Version Major reason for updating Issue date

1 Newly created. February 23, 2007

2Considered the findings of the internal review (April, 2007) and 1st Internal Audit.

May 10, 2007

3Considered the findings of the ISO Certification Audit and internal review, and reflected the change in the quality policy.

October 19, 2007

4Considered the change in the Tsukuba Institute organization and the findings of the internal review (April, 2008).

May 22, 2008

Table 3. History of updating the Quality Manual


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4. ISO common education

Table 4 shows the summary of ISO common education in

BRC.

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 3ISO9000 Top ManagementEducation

External 6

Total 119

Table 4. Summary of ISO common education executed in BRC (as of April 1, 2008)

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.

Sequence number (Timing planned)

Plan tracking #

Date executed Department audited Audit team leaderNumber of

nonconformities

raised

Number of

Opportunities

for

Improvement

raised

1st(before ISO

Certification Audit)

1 May 11, 2007 Director of BRC Dr. Yoshimi BENNO 0 0

2 April 20, 2007Management representative

and Support UnitMs. Kaoru SAIJO 2 4

3 April 20, 2007 Cell Engineering Division Dr. Masako TAKASHIMA 6 1

4 April 24, 2007 Microbe Division Ms. Emi IIMURA 18 1

2nd(before 1st ISO

Surveillance Audit)

5 November 8, 2007 Director of BRC Dr. Yukio NAKAMURA 0 0

6 November 6, 2007Management representative

and Support UnitDr. Yoshimi BENNO 0 0

7 November 7, 2007 Cell Engineering Division Dr. Motofumi SUZUKI 2 2

8 November 12, 2007 Microbe Division Dr. Kaoru FUKAMI 1 2

3rd(before 2nd ISO

Surveillance Audit)

9 June 20, 2008 Director of BRC Dr.Yukio NAKAMURA 0 1

10 June 4, 2007Management representative

and Support UnitDr. Takashi HIROYAMA 1 2

11 May 29, 2008 Cell Engineering Division Dr. Takashi ITO 1 5

12 May 30, 2008 Microbe Division Dr. Kazuhiro SUDO 3 4

Table 5. List of internal audits executed

6. 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.

Sequence number

Timing planned Date executed Main participants

1stAfter 1st Internal Audit, and before

ISO Certification AuditMay 21, 2007

Dr. Yuichi OBATA, Mr. Tsutomu KUBOTA, Dr. Yukio NAKAMURA,

Dr. Yoshimi BENNO

2ndAfter 2nd Internal Audit, and before

1st ISO Surveillance AuditDecember 18, 2007

Dr. Yuichi OBATA, Mr. Tsutomu KUBOTA, Dr. Yukio NAKAMURA,

Dr. Yoshimi BENNO

3rdAfter 3rd Internal Audit, and before

2nd ISO Surveillance AuditJune 27, 2008

Dr. Yuichi OBATA, Dr. Kuniya ABE, Dr. Yukio NAKAMURA, Dr.

Yoshimi BENNO

Table 6. List of management reviews executed


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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).

Surveillance AuditDate

AuditorDepartment audited Conclusion and finding

1stJanuary 8, 2008

Mr. Tomoaki MIZUSHIMA (Lead Auditor of BVJC)

Director of BRCManagement representative (Deputy director of BRC)Cell Engineering Division

Microbe Division

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.

2ndJuly 18, 2008

Ms. Kazue ITO (Lead Auditor of BVJC)

Same as above

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.

Table 7. List of ISO9001 Surveillance Audits executed

Support Unit for Quality Management

Documents

Transcript of Support Unit for Quality Management