口香糖公司质量管理系统要求.docx

文件排版存档编号：[UYTR-OUPT28-KBNTL98-UYNN208]
口香糖公司质量管理系统要求
WQMS 120 05/27/02 Factory Document Control & Revision
Controlled documents generated outside the Factory shall be controlled by the originating organization ., R&D, CQA) to assure the most current approved documents are available to the Factory. Factory Management shall meet the document control requirements of the originating organization. The documents shall be maintained as confidential, secured, and protected from damage. Examples of controlled documents are as follows:
Formulas
Manufacturing Procedures
Analytical Test Methods
Ingredient & Finished Product Specifications
Factory controlled documents shall meet the following requirements:
Examples of Factory documents are as follows:
Batch records,
Factory procedures and Work Instructions
Bill Of Materials (BOM)
Regulatory reports & legal documents
Documents shall be authored by persons knowledgeable in the subject matter of the document
Documents shall include, but not be limited to:
Unique title
Identification number
Revision number and/or date
Revision page
Page number
Author
Area of applicability ., sheeting, receiving, mixing)
Approvals
Documents shall be regulated to maintain security and confidentiality, and protected from damage.
A change to Factory documents shall include:
What change was made
Date change becomes effective
Factory approvals
The Factory shall have documented procedures for:
Identifying controlled documents
Scheduled review/revision of documents
Marking and control obsolete documents
Assuring the most current issue is available at point of use
The Factory shall have a documented procedure for archiving documents which includes, but is not limited to:
Responsibilities
Method
Location
Archiving methods include maintaining:
Hard copies
Microfilm
Electronic files
Factory records shall be