08.10.2018 Views

My Reading on ASQ CQA HB Part I-IA~IE-s

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<strong>Part</strong> IE1<br />

IE1-Gossip<br />

One way to work through the lack of a security clearance is to be<br />

c<strong>on</strong>stantly escorted, with classified areas, equipment, and activities<br />

shielded from view. This way, the auditor can evaluate part of the<br />

process and interview the people <strong>on</strong> the line.<br />

Some products may<br />

be adversely impacted by the presence of auditors<br />

or by the auditor’s health. For example, some pharmaceutical<br />

products may be sensitive to people with certain medical c<strong>on</strong>diti<strong>on</strong>s.<br />

Medical tests may need to be performed and results evaluated<br />

before the auditor is permitted to enter the processing facility. Wearing<br />

appropriate pers<strong>on</strong>al protective equipment such as gowning to<br />

limit human exposure may be sufficient to protect the product from<br />

humans.<br />

Charlie Ch<strong>on</strong>g/ Fi<strong>on</strong> Zhang

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