箭牌公司质量管理系统要求.doc

WQMS 120 05/27/02 Factory Document Control Revision 4.1 Controlled documents generated outside the Factory shall be controlled by the originating organization (e.g., RD, 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: 4.1.1 Formulas 4.1.2 Manufacturing Procedures 4.1.3 Analytical Test Methods 4.1.4 Ingredient Finished Product Specifications 4.2 Factory controlled documents shall meet the following requirements: 4.2.1 Examples of Factory documents are as follows: Batch records, Factory procedures and Work Instructions Bill Of Materials (BOM) Regulatory reports legal documents 4.2.2 Documents shall be authored by persons knowledgeable in the subject matter of the document 4.2.3 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 (e.g., sheeting, receiving, mixing) Approvals 4.2.4 Documents shall be regulated to maintain security and confidentiality, and protected from damage. 4.2.5 A change to Factory documents shall include: What change was made Date change becomes effective Factory approvals 4.3 The Factory shall have documented procedures for: 4.3.1 Identifying controlled documents 4.3.2 Scheduled review/revision of documents 4.3.3 Marking and control obsolete documents 4.3.4 Assuring the most current issue is available at point of use 4.4 The Factory shall have a documented procedure for archiving documents which includes, but is not limited to: Responsibilities Method Location 4.5 Archiving methods include maintaining: Hard copies Microfilm Electronic files 4.6 Factory