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Quality Manual REV 11.pdf - Norman Filter Company

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<strong>Norman</strong> <strong>Filter</strong> <strong>Company</strong>, L.L.C. QMS Policy <strong>Manual</strong> Page 26 of 40<br />

d) The results of changes to production processes shall be assessed to confirm that<br />

the desired effect has been achieved without adverse effects to product quality.<br />

7.5.5 Control of Production Equipment, Tools and Numerical Control (NC) Machine<br />

Programs<br />

a) Production equipment, tools and program are validated prior to use and<br />

maintained and inspected periodically according to documented procedures.<br />

Validation prior to production use includes verification of the first article<br />

produced to the design data/specification.<br />

b) Storage requirements, including periodic preservation/condition checks, are<br />

established for production equipment or tooling in storage.<br />

7.5.6 Control of Work Transferred, on a Temporary Basis, Outside the<br />

Organization’s Facilities<br />

When planning to temporarily transfer work to a location outside <strong>Norman</strong> <strong>Filter</strong><br />

<strong>Company</strong>’s facilities, there is a process to control and validate the quality of the work.<br />

7.5.7 Control of Service Operations<br />

While <strong>Norman</strong> <strong>Filter</strong> <strong>Company</strong> does not currently provide “servicing” as a contractual<br />

requirement, the following will be addressed should this become a requirement for one<br />

or more customers: Service operation processes shall provide for<br />

a) A method of collecting and analyzing in-service data,<br />

b) Actions to be taken where problems are identified after delivery, including<br />

investigation, reporting activities, and actions on service information consistent<br />

with contractual and/or regulatory requirement,<br />

c) The control and updating of technical documentation,<br />

d) The approval, control, and use of repair schemes, and<br />

e) The controls required for off-site work (e.g., organization’s work undertaken at<br />

the customer’s facilities).<br />

7.5.8 Validation of Processes for Production and Service<br />

First Article Inspection – <strong>Norman</strong> <strong>Filter</strong> <strong>Company</strong> has a process for the inspection,<br />

verification, and documentation of a representative item from the first production run of<br />

a new part or assembly to verify the production processes, production documentation and<br />

QM01-01, Rev.11, 07/12/12

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