as9100内部审核程序英文版

Subject:
Rev. A QP 1700
INTERNAL AUDIT
Effective
Page 1 of 4
Date:
ASC Procedure Approved By:
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
audited.
INTERNAL AUDIT
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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.T he 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.
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.
INTERNAL AUDIT
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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.
6.8Internal Quality Audit Nonconformance Reports are reviewed using the Summary of
Findings at the Management Review Meetings. The Management Representative。