Document name:
Procedure for Documents & Materials
Issue date: Nov. 20, 2002
Version: 01
Pages: 1st of total 3 pages
1. Purpose:
This document specifies the compilation, approval, modification and issue of the company’s internal quality documents. 2. Applicable scope:
This document is applicable to the control and management of the quality documents within the company. 3. Responsibilities:
3.1 The quality document worked out by a department shall be checked and approved by the supervisor of the department, and any changes to the document shall be subject to the check and approval of the department issuing it.
3.2 The department issuing the quality document shall record the issue and revision of the document in a control page.
3.3 Any changes to the document shall be performed by the original department issuing the document, and all the changes shall be clearly noted, so are the change date and issue version of the quality manual. 4. Procedures:
4.1 Compilation and approval of the quality document:
4.1.1 The quality manual shall be worked out by the manager’s representative, approved and issued by the general manager;
4.1.2 The Operation Procedures shall be worked out by the Manager’s Representative, and approved and issued by the General Manager.
4.1.3 The Operating Specifications of various departments shall be worked out by the designated person of the departments, and approved by department supervisors or managers.
4.1.4 Other quality documents are worked out by the various responsible departments as follows:
- R&D Dept.
- ME Dept.
- QC Dept.
4.1.5 These quality documents are worked out on the basis of design specifications, supplier specifications, customer documents, international standards, quality standards, applicable laws and regulations, and other applicable documents.
4.1.6 The department responsible for working out the quality document shall first submit the document for approval. The approved document serves as the original, saved in the Documents Control Center under the QC Dept.
Document code: COP1.1
Document name:
Procedure for Documents & Materials
Issue date: Nov. 20, 2002
Version: 01
Pages: 2nd of total 3 pages
Quality documents include the following items:
----Quality Manual
----Operation Procedures
---- Engineering design document (included in the main files for the products)
---- Specifications, including
Operating specifications for the various departments
IQC parts test specification
ME Dept. instrument measurement specification
IE Operation Instruction Specification (OIS) (please refer to 4.2.6)
Quality Assurance (QA) finished products test specification
4.2 Control over issue of quality documents:
4.2.1 The department issuing quality documents has to deliver the original to the Documents Control Center, who shall copy and issue the documents, save a control table, and list the following information in the table every time of issue:
---- Document code
---- Issue date
---- Document name
----Version
---- Recipient’s signature
4.2.2 The department receiving the document shall sign on the control table to indicate that the department has received the document. The Documents Control Center shall issue documents according to the list of documents users, and ensure that the using departments can timely use the up-to-date and effective versions.
4.2.3 If a new document replaces the previously revised document, then the document receiving department shall replace the old document with the new one, while the old one shall carry the stamp of “Rejected document”, and shall be retrieved and destroyed by the Documents Control Center.
4.2.4 For the technical documents included in the main file issued by the R&D Dept., the Documents Control Center shall carry the stamp “Rejected document” on the cover of the revised document, and the document shall be destroyed or handled by the receiving department on its own.
4.2.5 The Documents Control Center shall carry the stamp “Rejected document” on the cover of the originals of the rejected documents, while the originals have to be kept for another three years before being handled.
4.2.6 The initial version of IE Operation Instruction Specification (OIS) is used at earlier stages of trial production, as a result, the ME Dept. shall apply a version “00” on the initial OIS, as well as “Initial version” for identification.
The ME Dept. shall work out, revise and keep the initial version of OIS, and it is not required to be sent to the Documents Control Center.
Document code: COP1.1
Document name:
Procedure for Documents & Materials
Issue date: Nov. 20, 2002
Version: 01
Pages: 3rd of total 3 pages
Only the formal OIS, namely, version 01 OIS shall be sent to the Documents Control Center for filing or issue control.
4.3 Control over changes to quality documents
4.3.1 The Documents Control Center shall keep documents including external documents converted into internal documents by related departments, and the Documents Control Center shall keep the versions well when there are any changes to the documents.
4.3.2 All the changes and the necessities for changes shall be checked by the supervisors of the original departments issuing documents, so as to verify the necessities for changes.
4.3.3 When the requests for changes are approved, the supervisor of the department shall send an employee to perform changes, or handle the changes.
4.3.4 The changes to quality documents shall reflect their versions and issue dates by writing clearly on them, so that there will be no confusion for dates and versions.
4.3.5 If there are any damages to the changed documents or similar versions of documents, the above-mentioned rules shall be followed for processing.
4.4 Keeping documents:
The copies of the quality documents of various departments shall be properly kept, no change or writing shall be done on them, and the integrity of the documents shall be ensured.
4.5 Identification and control of external documents:
When receiving documents form outside, the various departments shall not use them directly in the company. When necessary, they can be converted into internal documents of the company, and issued according to the above-mentioned regulations.
