Quality Systems Assessment

Internal Audit Report

Prepared for:

Company XXX

REPORT NUMBER 020401

Report date: 5 April 2002

XXXXXXXXX
Clearfield, UT 84016
Assessment Report Summary

Purpose
XXXXXX, acting as Company XXX’s internal auditor conducted a Quality Management
System (QMS) assessment at Company XXX for compliance to ISO 9001:2000 on the 1 st
and 2nd of April 2002 at their facility located at XXXXXXX, Clearfield, Utah. The purpose
of this report is to summarize the results of the QMS Assessment.

Scope
This report consists of a set of assessment documents and completed forms when taken
together detail the results of the QMS Assessment. This report includes:

Information About the Company

This document contains information about the Company at the time of the QMS
Assessment.

Assessment Plan and Details

This document sets forth other information regarding the auditors and
documentation used.

Positive Findings
This document addresses the positive or compliance issues.

Review of Nonconformances
This document addresses the specific nonconformities and/or observations found
during the QMS Assessment.

Observations
This document contains observations by the auditor that may be considered by
Company XXX for potential system improvement.

Assessment Conclusion
This document contains conclusion statements about the status of the QMS.

Attachment
A copy of the completed audit checklist is attached.
Information About the Company

Name & Address: Company XXX

XXXXXXXXXX
Clearfield, UT, 84016

Location Audited: Same as above

ISO Standard: ISO 9001:2000

ISO Clause(s)
Not Applicable: Company XXX is exempt from the requirements of clause
7.3 (Design and Development) because the customer is
design responsible in all cases. This exclusion is
documented in the Quality Manual on pages 12 and 28.

Scope of Business: Rework of government furnished aerospace assemblies

Audit Contact: XXXXXXXX

Phone: (XXX) XXX-XXXX

Fax: (XXX) XXX-XXXX

EAC/SIC 4581, 3728

Number of employees
at this location: Approx. 28

Language: English

Special expertise or
equipment required: N/A

Audit Team XXXXXXXXXXX – Lead Auditor

Assessment Plan and Details

Assessment Purpose: To review the Quality Management System to the

requirements of ISO 9001:2000 as a means to
assist the company in their ISO implementation &
maintenance. Also to assess Company XXX’s
readiness for an ISO 9001:2000 registration audit.

Assessment Audit Scope: This audit was a complete Quality Management

System audit. Although the 7.3 is exempted, the
requirements were reviewed to ensure that these
activities are not actually required or performed by
Company XXX.

Quality Manual: Current Rev Date: Rev. A dated 3/20/02

Implementing Documentation: Procedures, various revisions; work instructions,

various revisions; supporting forms and records.

Document Review: N/A

Document Review
C.A. Closed? N/A

Checklist used: Company XXX’s Internal Quality Management

System ISO 9001:2000 audit checklist (MSI 061
Rev. 2/26/02)
Positive Findings
Listed below are only a few of the many positive findings identified during the audit.

5.1 Management Commitment

ISO 9001 requires that top management provide evidence of its commitment to
the development and implementation of the Quality Management System.

Company XXX has shown commitment to developing and implementing an ISO

9001:2000 compliant Quality Management System. This is evidenced by
management’s direct involvement in processes, commitment of resources,
management review activities, etc.

7.4.2 Purchasing Information

ISO 9001 requires that purchasing information adequately describe the product
to be purchased.

Company purchase orders are very thorough in describing purchased product

requirements. This includes all applicable qualification, testing, and special
requirements.

7.5.4 Customer Property

ISO 9000 requires the organization to exercise care with customer-owned

property while it is in their control. If any customer property is lost or damaged
the customer be notified and records maintained.

Company XXX has very good controls for customer-owned property. Excellent
record keeping and communication processes are in place. Company XXX’s
customer provides feedback regarding this control indicating a high level of
customer satisfaction.
 Review of Nonconformances

4.2.3 Control of Documents

ISO 9001:2000 states “Documents required by the quality management system

shall be controlled.”

In the XXXXX area, a binder with sketches, part numbers, dimensions, and
instructions was being used which is not under control. Also, in the XXXX clean
room, there was a Technical Order (external document) that was not stamped
according to the document control procedure requirements (QOP-4.2.3). This
Technical Order was not on the master list of external documents, and had the
potential of not being updated should the customer issue a revision.

6.2.2 Competence, Awareness and Training

ISO 9001:2000 states “The organization shall… ensure that its personnel are
aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives…”

Although all personnel interviewed were aware of the importance of their

activities, they did not know what the quality objectives were. Because of this
they were not aware of how their activities contribute to the achievement of the
quality objectives.

7.6 Control of Monitoring and Measuring Devices

ISO 9001:2000 states, “Where necessary to ensure valid results, measuring

equipment shall… be calibrated or verified at specified intervals, or prior to use,
against measurement standards traceable to international or national
measurement standards.” It also states, “Where necessary to ensure valid
results, measuring equipment shall… be identified to enable the calibration
status to be determined.”

In the XXXX area, multiple gages were available for use that had not been
calibrated per the requirements of ISO 9000, and were not identified regarding
calibration status. This includes a 0.25” nogo gage, a dial caliper (last calibrated
in 1992), and several personal tools such as steel rulers, etc. Also, in the XXXX
clean room were approximately eight go/nogo gages, which records indicated
had been internally calibrated, but had no calibration status identified on the
tools.

8.3 Control of Nonconforming Product

ISO 9001:2000 states, “The organization shall ensure that product which does
not conform to product requirements is identified and controlled to prevent its
unintended use or delivery.”
 Multiple locations have nonconforming materials that are not identified as
required, including:
 Several large cardboard boxes containing scrap and nonconforming parts
removed from assemblies.
 A cardboard box lid that held nonconforming XXXXXX parts removed from
assemblies prior to being placed in a scrap container.
 Racks containing “repairable” customer owned material received for
Company XXX to refurbish per contract.

8.5.3 Preventive Action

Company XXX’s Preventive Action procedure (QOP-8.5.3) requires that

preventive actions be documented on the Corrective and Preventive Action form
(MSI 035).

All of the Preventive Actions resulting from the Management Review held on
1/29/02 were documented in memo form, not on form MSI 035 required.
 Observations

5.6 Management Review

Company XXX’s Quality Manual requires management review inputs, including

government audit results of property administration system and effectivity of
corrective action items closed.

The Management Review meeting held on 1/29/02 did not include the
government audit results of property administration system, which was
confirmed to have been received from the customer. Also, the closed corrective
actions were not reviewed as required. This does not meet the Quality Manual
requirements. However, prior to the close of the audit Company XXX completed
corrective action and revised the management review input form to ensure that
these items will be reviewed in the future.
Assessment Conclusion:

Overall, Company XXX’s Quality Management System is well developed and

implemented. The few issues identified during the internal audit are not major in
nature and are correctible with the right effort.

The employees are dedicated to providing a high quality product, were open with the
auditor, and were very polite and honest.

There are many working processes in place at Company XXX to enhance the business
and increase customer satisfaction.

XXXXXXXXX

Lead Auditor

Distribution: XXXXXXXXXXX, Quality Assurance Manager

XXXXXXXXXXX, Lead Auditor