Operational Procedure MIYOSHI PRECISION (MALAYSIA) SDN
BHD
Control of Records
Operational Procedure : OP-4.2.4 Revision: 6 Page 1/5
Revision History
Rev No Details of Revision Date
00 Initial Release 01.01.02
01 An operational procedure has been updated to include 24.04.06
environmental aspects.
02 To update the procedure and to add-in TS16949 requirement as a 28.02.07
current practice. Additional clause for V Record list : 1.1, 1.2, 1.3,
1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 1.10, 1.11, 1.12 and 1.13.
03 To update the procedure and to add-in Revision History as a front 30.08.07
page for procedure.
04 Upgrade to ISO 9001:2008 requirement 14.10.10
05 Changes at approval Authorities and other minor amendments 13.12.10
06 Changes at approval Authorities and other minor amendments 03.05.11
Approval Authorities
Prepared Reviewed Reviewed Reviewed Approved By
By By By By
Name Kala Allan Teen Nicole Lee S.H.Yu C.A Tan
Date 03.05.11 03.05.11 03.05.11 03.05.11 03.05.11
Designation Doc. Cont. EMR OSHMR QMR GM
Control of Records
Operational Procedure : OP-4.2.4 Revision: 6 Page 2/5
Signature
Responsible Outline of Procedure Interfaces
Related Dept Establishment of Initiate Quality Records
Quality Records
Related Dept Quality Records Refer to ESH/Quality Record
Custodian
List
ESH/Quality Records
Related Dept Storage Area Refer to ESH/Quality Record
List
ESH/Quality Records
Related Dept Retention Periods Refer to ESH/Quality Record
List
Control of Records
Operational Procedure : OP-4.2.4 Revision: 6 Page 3/5
I PURPOSE
The purpose of this procedure is to provide for a system and instruction, and, to
assign responsibilities for establishing, storage and retention of environmental, safety
& health and quality records.
II APPLICATION
This procedure applies to all records demonstrating conformity of products and the
environmental, safety & health and quality system, and in particular records listed in
Part V of this procedure.
III RESPONSIBLE
This procedure concerns all departments that establish and maintain records. Part V
of this procedure lists the relevant departments for each type of record.
IV PROCEDURE
1 General
1.1 Environmental, Safety & Health and Quality records provide the evidence that
process, products and environmental , safety & health matters meet Miyoshi
requirements. That the finished products conform to specifications and the
environmental, safety & health and quality system is operated in accordance with
documented procedures and that it is effective. Where required, records also include
traceability information.
2 Establishment of records
2.1 Records normally established by personnel directly involved with the task, operation,
or activity whose results need to be recorded.
2.2 Specific record formats are usually prescribed by procedures that call for their
establishment. These can be forms, reports, minutes of meetings, sign-off or stamps
placed on other documents and so forth.
2.3 As the company progress from paper to electronic systems, growing number of
records are being established and maintained in electronic media. These may be in
the form of text documents, spreadsheets, databases and specialized software.
Control of Records
Operational Procedure : OP-4.2.4 Revision: 6 Page 4/5
3 Identification
3.1 Records are identified or referenced to the product, person or event to which they
pertain. Records are dated and the function or people who established the record are
identified.
4 Indexing and storage
4.1 Records are indexed and grouped to facilitate their retrieval. Files, binders, drawers,
cabinets, computer disks and tapes, etc., containing records are clearly labeled with
identification of their content.
4.2 Records are normally stored by the same department who established the record.
Records are stored in a dry and clean location.
4.3 Records and other environmental, safety & health and quality documents shall not be
stored in private desk drawers or other obscure locations that are not generally
known.
4.4 Electronic records are regularly backed up or protected by a password.
V RECORDS LIST
1.1 Where applicable, the record retention shall satisfy regulatory and customer
requirements. The following are the basic guideline for record retention.
1.2 Sales records: Offers, sales orders, and other documents established in the course of
processing, negotiating, and implementing contracts and orders. Retained by Sales &
Marketing for the lifetime of the product or three years, whichever is greater.
1.3 Subcontractor evaluation and performance records: Documents demonstrating
subcontractor quality capability and performance, as well as, its ability to prevent
pollution & accidents. Retained by Purchasing while the subcontractor is active or
three years, whichever is greater.
1.4 Purchase orders: Purchasing documents for procurement of materials, components,
products, and services to be incorporated into the finished product. Retained by
Purchasing for the lifetime of the product or three year, whichever is greater.
1.5 Production and product (batch) verification records: Work orders, traceability
records, material certificates, control charts, inspection and test results, etc. Retained
by Production for the lifetime of the product or three year, whichever is greater.
Control of Records
Operational Procedure : OP-4.2.4 Revision: 6 Page 5/5
1.6 Nonconforming product records: Product nonconformity reports. When these
records pertain to reworked or repaired product they are kept by Production together
with other product-related records. When the product is scrapped or regraded, Quality
Assurance retains the records for a period of three years.
1.7 Calibration certificates/records: Measuring and monitoring equipment calibration
certificates/records. Retained by Quality Assurance or LRPC for a period of three
years.
1.8 Delivery orders: Records identifying the shipping consignee address, shipping date,
products to be shipped, labeling requirements and transportation mode or carrier.
Retained by Shipping for the lifetime of the product or three years, whichever is
greater.
1.9 Management Review records: Minutes of management review meetings and other
management review input and output documents. Retained by Document Controller
for a period of three years.
1.10 Corrective and Preventive Action records: Corrective and Preventive Action
Reports. Retained by Quality Assurance for a period of three years.
1.11 Customer feedback and complaints records: Files with customer feedback and
complaints, including communication records and resolutions. Retained by Sales &
Marketing for a period of three years.
1.12 Internal audit reports: Internal audit reports, including audit findings and associated
corrective and preventive actions. Retained by Document Controller for a period of
three years.
1.13 Training records: Personnel training records. Retained by HR & Admin for a period
of three years or after termination of employment.
1.14 The details summary of the above records can be referred to the Environmental
Record List and Quality Record List.
VI ASSOCIATED DOCUMENTS
Operational Procedure OP-4.2.1: Environmental, Safety & Health and Quality
System Documentation
Control of Records
Operational Procedure : OP-4.2.4 Revision: 6 Page 6/5
Operational Procedure OP-4.2.3: Control of Documents
VII APPENDIX
Nil
