INTERNAL AUDIT REPORT

To: Bev Cameron & Kathy Thompson Date: 10/02/2003

From: Christy Becerra Cc: Eric Tzeng, Kyle Lukens

Subject Internal Audit (Purchasing)

Audit Area: 7.4 Purchasing Auditee: Kathy Thompson

Audit Date: 10/01/2003 Auditor: Christy Becerra

Scope and Objectives of Audit:

The scope and objective of the internal audit was to determine compliance with ISO 9001:2000
section 7.4 Purchasing.

No exit meeting was held at the time the audit was concluded. Follow-up meeting to review non-
conformance and observations to be scheduled.

Audit Findings and Observations:

Requirement 7.4.1 Purchasing process

“The organization shall ensure that purchased product conforms to specified purchase
requirements. The type and extent of control applied to the supplier and the purchased product
shall be dependent upon the effect of the purchased product on subsequent product realization or
the final product.”
The organization shall evaluate and select suppliers based on their ability to supply product in
accordance with the organization's requirements. Criteria for selection, evaluation and re-
evaluation shall be established. Records of the results of evaluations and any necessary actions
arising from the evaluation shall be maintained (see 4.2.4).

Finding: No records of evaluation on Suppliers that have a “Grandfathered” status. Procedure

W90620002 rev. D States in (Step # 2, bullets 1 and 2) Short form will be used for minor level of
procurement needed – bullet 2 states- the detailed form will be used for major levels of
procurement.

Finding: No criteria in place for the re-evaluation of suppliers.

Comments: Currently only tracking top dollar suppliers.

Finding: No Records of evaluation of suppliers of Unisys product.

Finding: No evidence or records available that subcontractors performing calibration of

inspection, test and measuring equipment affecting product quality have been approved for the
performance of this service.

Observation: No formal process in place to issue supplier corrective action or how to preclude
the use of disapproved suppliers.
Requirement 7.4.2 Purchasing Information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.

Finding: No evidence that adequate information covering these requirements is being flowed
down to suppliers of calibration services, especially in regards to ISO9001 7.6 a) requirement
“Where necessary ensure valid results, measuring equipment shall…
a) be calibrated or verified at specified intervals, or prior to use, against measurement
standards traceable to international or national measurement standards; where no such
standards exist, the basis used for calibration or verification shall be recorded;.” No
evidence that requirements are flowed down to calibration supplier to allow compliance to
requiring calibration “…against certified equipment having a known valid relationship to
internationally or nationally recognized standards.”

Requirement 4.1 General Requirements: and 7.4.2 Purchasing Information (see above)
Where an organization chooses to outsource any process that affects product conformity with
requirements, the organization shall ensure control over such processes. Control of such
outsourced processes shall be identified within the quality management system.

Finding: Methods of control for any outsourced processes such as embossing or calibration need to be
identified in the quality manual (see 4.2.2) or other documentation such as purchasing information.