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Regional Basic Professional Training Course in Korea

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<strong>Regional</strong> <strong>Basic</strong> <strong>Professional</strong> <strong>Tra<strong>in</strong><strong>in</strong>g</strong> <strong>Course</strong> (BPTC) on Nuclear Safety<br />

7.4.3.3 Other Types of Audits<br />

In addition to Quality System audits described <strong>in</strong> this chapter, other types of quality<br />

audits most frequently referred to <strong>in</strong>clude: (1) Product Audit, and (2) Process Audit.<br />

Product Audit ‐ A product Audit is the exam<strong>in</strong>ation, <strong>in</strong>spection or test of a product which<br />

has been previously accepted for the characteristics be<strong>in</strong>g audited. Such an audit is a re‐<br />

<strong>in</strong>spection and retest of the product which has already been accepted or review of<br />

documented evidence of acceptance. It <strong>in</strong>cludes perform<strong>in</strong>g operational tests to the same<br />

requirements used by manufactur<strong>in</strong>g, us<strong>in</strong>g the same production test procedure, methods<br />

and equipment. The audit will measure the level of product conformance to specified<br />

standards of workmanship, performance, and quality. It is an <strong>in</strong>dicator of quality go<strong>in</strong>g to<br />

the customer. The audit frequently <strong>in</strong>cludes an evaluation of packag<strong>in</strong>g; exam<strong>in</strong>ation for<br />

cosmetics; check for proper documentation and accessories such as proper tags, stamps,<br />

shipment preparation and protection. The audit may <strong>in</strong>volve a check of accuracy of the<br />

tests, test equipment and test procedure.<br />

Process Audit ‐ A process Audit is verification by evaluation of manufactur<strong>in</strong>g or test<br />

operation aga<strong>in</strong>st documented <strong>in</strong>structions and standards, to measure conformance to<br />

these standards and the effectiveness of the <strong>in</strong>structions. Such an audit is a check of<br />

conformance of process, personnel and equipment to def<strong>in</strong>ed requirements such as time,<br />

temperature, pressure, composition, amperage, component mixture, etc. It may <strong>in</strong>volve<br />

special processes such as heat treat<strong>in</strong>g, solder<strong>in</strong>g, plat<strong>in</strong>g, encapsulation, weld<strong>in</strong>g and<br />

nondestructive exam<strong>in</strong>ation. The audit is a check for adequacy and effectiveness of the<br />

process controls over the equipment and operators as established by procedures, work<br />

<strong>in</strong>structions, and process specifications.<br />

7.4.3.4 The Audit Process<br />

Quality audits must be prepared for, i.e. plann<strong>in</strong>g ahead, and conducted, and have the<br />

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