美赞臣企业供应商巡检报告.docVIP

第 PAGE 3 页 共 NUMPAGES 12 页 NOTE： An electronic copy of this document is available Date: 2004.12.27 version: 01 Auditor(s) Name: Bob Yu、Steven Yuan MEAD JOHNSON NUTRITIONALS PACKAGING SUPPLIER AUDIT PLAN Opening Meeting: Introduction auditors and Huate management Team Objective: Additional GMP assessment (MJN requirements) to ascertain supplier’s qualification into MJN (GZ)’s list of approved scoop supplier Audit scope: Raw material reception and acceptance Finished material and dispatch In-process Operations Quality Assurance/Quality Control/ Laboratories Engineering Utilities (air, water, steam and compressed air). Equipment ( maintenance, cleaning procedures and calibration). GMP Training and Pest Control Documentation Closing Meeting: Discussion and clarification of findings Response time NOTE: STANDARDIZED AUDIT RATINGS 审核评定标准。 Acceptable （合格）- No observations.? Or, if observations are noted, they can be corrected within a reasonable period of time (90 days), and none are deemed to present significant regulatory risk.? No follow up audit is required, although monthly action plan updates must be received from the supplier.Provisional （需改进） – Numerous observations noted, enough to pose a moderate regulatory risk to the product and/or MJ operations. Immediate attention should be given to addressing these concerns. A follow up audit must be scheduled, unless the auditor feels that sufficient evidence of corrective action has been provided within a reasonable period of time. Unacceptable （不合格）- Critical observation(s) noted. An immediate focused effort is required to correct deficiencies. Global Quality Assurance must be contacted immediately to determine the approval status of a supplier receiving an unacceptable rating. A recommendation to Global Procurement to cease operations or not to establish a business relationship with a firm may result.Definitions 定义: Observations 一般不符合项 - those findings that pose a