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REPORT NUMBER 020401 Report date: 5 April 2002 XXXXXXXX X 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 1st 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.
Informati on About the Company
Name & Address:
Company XXX XXXXXXXXXX Clearfield, UT, 84016 Same as above ISO 9001:2000 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. Rework of government furnished aerospace assemblies XXXXXXXX (XXX) XXX-XXXX (XXX) XXX-XXXX 4581, 3728 Approx. 28 English N/A XXXXXXXXXXX – Lead Auditor
Location Audited: ISO Standard: ISO Clause(s) Not Applicable:
Scope of Business: Audit Contact: Phone: Fax: EAC/SIC Number of employees at this location: Language: Special expertise or equipment required: Audit Team
Assessment Plan and Details
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. 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. Current Rev Date: Rev. A dated 3/20/02
Assessment Audit Scope:
Implementing Documentation: Procedures, various revisions; work instructions, various revisions; supporting forms and records. Document Review: Document Review C.A. Closed? Checklist used: N/A N/A Company XXX’s Internal Quality Management System ISO 9001:2000 audit checklist (MSI 061 Rev. 2/26/02)
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:
• • • 8.5.3
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.
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.
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.
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