各位高手，我单位刚刚进行了API的外审，审核员开具了6个不符合项，其中一个领导叫我来进行整改关闭；由于我不懂英语，求各位老大帮忙，不胜感激。内容如下：
APICPD AUDIT ACTION REPORT
Auditor: Henry Liu Huanfei
AAR Date: January 11 - 13, 2009
AAR No: 1/6
Organization:Petroleum Machinery Factory of Bohai Petroleum Manufacturing Co., Ltd.
Location: Renqiu, Hebei, ¬¬PRC
Audit Type (check all that apply)
Monogram Initial Renewal Re-Audit Periodic Other
QMS Initial Surveillance Re-Audit Transfer Other
AAR Written Against (Identify all applicable):
ISO 9001/API Spec Q1/TS-29001 Section No: 7.1c)
Organization Requirement (Procedure, WI, Drawing, etc.) No: HSJ/Q/7.04 02/02 Rev. A
Product Specification/Paragraph No: API-16C, 4.1.1
AAR Classification:
Concern (No response required) Note: API reserves the right to upgrade to a Nonconformity; Auditee encouraged to address within QMS
Nonconformity – Isolated (Isolated or limited occurrence)
Nonconformity – Systematic (system failure or multiple occurrence)
Nonconformity/Concern Description:
API 16C Metallic Materials Specification, HSJ/Q/7.04 02/02 Rev. A May 20, 2009 did not specified the materials of 35CrMo, which is used for choke manifold assembly as per API-16C, 4.1.1 for 35CrMo.
Requirement:
API-Q1, 8th Ed, 7.1 c) Product realization, Planning of product realization “In planning product realization, the organization shall determine the following, as appropriate: c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;”
API-16C, 4.1.1 Materials requirements, for pressure containing parts shall be prepared written specifications
Objective Evidence:
API 16C Metallic Materials Specification, HSJ/Q/7.04 02/02 Rev. A May 20, 2009
Auditor Signature:
Henry Liu Huanfei
Organization Representative Signature:
Response Instructions – PLEASE RESPOND TO THIS AAR WITHIN 60 DAYS
API will not review audits until responses to nonconformances raised therein have been received (as applicable). Failure to submit responses within 60 days from audit conclusion may result in the suspension of API Monogram Licenses and/or APIQR Certificates of Registration. When responding, please address each item listed below completely.
A. Identify the Root Cause(s) of Nonconformity – Provide a detailed explanation of the cause (i.e., “why” the nonconformity occurred). A simple re-wording of the nonconformity will not be accepted. Terms such as “oversight” or “human error” require further explanation.
B. Identify Action(s) Taken to Correct Nonconformity – API considers only actions that have been “completed” as acceptable. Future system revisions, training sessions, reviews, etc., though indicating intent, do not substantiate completed action. Corrective actions must include determination of competency of affected personnel to perform the required activities. Provide the Date of Completion/Implementation
C. Identify Action(s) Taken To Minimize the Likelihood of Recurrence – API considers only actions that have been “completed” as acceptable. Future system revisions, training sessions, reviews, etc., though indicating intent, do not substantiate completed action. Corrective actions must include determination of competency of affected personnel to perform the required activities. Provide the Date of Completion/Implementation
D. List of Supporting Documents – Any documentation that will substantiate the corrective action(s) and/or action(s) completed to minimize recurrence should be submitted with your response. This could include revised procedures, drawings, forms, ECOs, training
