AS9100程序 AS9100B_QP12-INTERNAL AUDIT

1.PURPOSE

1.1The purpose is to provide a procedure for conducting audits to determine whether

the quality management system:

1.1.1 Conforms to the requirements of AS9100 and to quality management system

requirements established by PRC-DeSoto International.

1.1.2 Is effectively implemented and maintained.

1.1.3 Meet Contract and Regulatory Requirements.

2.SCOPE

2.1 This procedure applies to the ASC Quality Management System. Flow-down shall

be areas described in the quality procedures, policies, and work instructions

affecting the quality of work are audited, including delegated quality activities. 3.RESPONSIBILITY

3.1 The Management Representative – Ensures that internal audits are performed

according to established process. Ensures that auditors are trained or plans for

audit.

3.2 Trained internal quality auditors (Audit Team) are responsible for conducting all

internal audits.

3.3The Management Representative ensures that internal auditors are trained,

prepares and keeps records of this training, prepares an audit schedule, completes

the Summary of Findings and tracks and verifies the timely closure of corrective

actions to Nonconformances and maintains records.

4.GENERAL

4.1 The Audits are performed by trained internal auditors independent of the functions

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audited.

5.DEFINITIONS

5.1Audit - systematic, independent and documented process for obtaining objective

evidence and evaluating it to determine the extent to which audit criteria are

fulfilled.

5.2Audit criteria - set of policies, procedures or requirements used as a reference.

5.3 Auditor – Person with the competence to conduct an audit.

5.4 Audit finding – Results of the evaluation of the collected audit evidence against

the audit criteria.

5.5Objective Evidence – Data that supports the existence of verification of

something.

5.6Nonconformity – Non-fulfillment of a requirement.

6.PROCEDURE

6.1The Management Representative plans and implements an audit schedule

ensuring that:

?Quality management system requirements are audited

?The frequency of audit is based on the status and importance of the process(s) and activity audited as well as previous audit results.The set time to complete audits is

within the month assigned.

6.2The Management Representative determines the audit scope, audit criteria and

assign an auditor(s) for completion of each audit. The selection of auditors for each

assignment ensures objectivity and impartiality of the audit process and those auditors do not audit their own work.

6.3Management Representative notifies the department manager of the audit by

forwarding a copy of the schedule when developed and revised.

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6.4The internal auditor contacts the appropriate departments to schedule a pre-audit

meeting where specific audit dates/times based on department and auditor schedules are

discussed. Internal auditors perform the audit.

6.5Auditors performs audits in a structured manner to accomplish the scope of the

audit assignment:

?Review assignment to determine audit scope, audit criteria.

?Schedule the audit with the audited.

?Review audit criteria, such as policies, procedures, contracts, requirements of AS9100 and prepare a QPF1700-1 Audit Checklist as appropriate to accomplish audit scope.

?Hold an opening meeting with audited to explain purpose and scope of the audit.

?Execute the audit by obtaining sufficient information or objective evidence to permit conclusions to be drawn regarding the conformance/nonconformance and

effectiveness of the area being audit.

?Collective information and objective evidence through interviews, examination of documents and records, observation of activities and conditions in the areas being

audited.

?Record observations for review to determine whether Nonconformances or potential Nonconformances exist.

?Review observations, taking into account their significance and drawing conclusions about conformance/nonconformance and effectiveness of the area at meeting

requirements and achieving quality objectives.

?Prepare nonconformance reports according to the Corrective and Preventive Action procedure taking care to include sufficient details and objective evidence.

?Hold a closing meeting with the audited to review and clarify the results and conclusions of the audit.

?Prepare an audit report that summarizes the audit conclusions and forwards to the Management Representative.

?Management Representative reviews the audit report and any recorded Nonconforming reports; obtains clarification from the auditor(s) as appropriate.

6.6 A copy of the Internal Quality Audit Nonconformance Report is sent to the audited,

(department manager). The audited investigates findings/observations. Managers review audit findings. The audited completes corrective action responses and send to the

Management Representative for review and approval within stated due date defined in the NCR form. Management Representative input/close audit in the Nonconforming

Database.

6.7The Management Representative assigns follow-up/verification of corrective action based

on the estimated completion date determined by the Manager.

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6.8Internal Quality Audit Nonconformance Reports are reviewed using the Summary of

Findings at the Management Review Meetings. The Management Representative

completes the Summary of Findings and tracks and verifies the timely closure of

corrective actions to Nonconformances.

6.9Management at the Quality Management Meetings determines the effectiveness of

implemented corrective actions and determines the need for additional corrective actions or re-audits when necessary. If it is determined by Management that a corrective action is ineffective, the appropriate Department Managers are notified and are responsible for

development of a revised plan for corrective action including completion dates. A new

NCR is written, and this revised plan is also tracked through Management Reviews.

Completion and verification of any issues are indicated on the Audit Nonconformance

Report.

6.10Records of internal audits are kept for 7 years under the control of the Quality Control

Department.

7.REFERENCE DOCUMENTS

7.1 QP 1600 – Control of Records

7.2 QPF1700-1 Audit Checklist form

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