Fluid Components International Quality Assurance Manual User Manual

Page 93

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DOCUMENT NUMBER

07QA070003

SUBJECT

Quality Manual

CAGE CODE

64818

RELEASE DATE

10-8-2012

SECTION

3

PAGE

20

CURRENT
REVISION

L

18

AUDITS

18.1

Internal Audits

An internal audit of the FCI Quality Assurance Program shall be performed per
Quality Assurance Procedure 04QA704008. This audit shall cover all sections of the
Quality Manual and applicable addendums. An Audit Plan shall be issued for each
Internal Audit. The Audit Plan will describe the audit team, audit timetable, and audit
assignments.

A report to Management (including the President) shall be issued at the end of the
audit describing the audit results. The report shall include copies of all Audit
Findings and discuss the status, adequacy, and effectiveness of the Quality System.
See Quality Assurance Procedure 04QA704008 for detailed instructions.

18.2

External Audits

FCI shall perform audits of vendors providing nuclear qualified items. The scope and
content of the audit shall be in accordance with Quality Assurance Procedure
04QA704008.

18.3

Vendor Surveys

The Company shall perform surveys of vendors providing calibration services and
testing services. Surveys of special process vendors shall be performed when
determined necessary by the Quality Assurance Manager. These surveys shall be
performed to determine the vendor‟s capability in complying with FCI contractual
requirements or determining continued compliance to contractual requirements. The
scope and content of the survey shall be in accordance with Quality Assurance
Procedure 04QA704044. Vendors surveyed shall also be evaluated for Critical Safety
Characteristics of their service.

18.4

Auditor Qualification

The audit or survey shall be conducted by a qualified Lead Auditor, and can be
assisted by other qualified Auditors. Auditors shall not have direct responsibility for
the activities being audited.

Auditor qualifications shall be documented and shall conform to the requirements of
Quality Assurance Procedure 04QA704054.

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