Archive for August, 2010

DISCUS for 21 CFR Part 820

Monday, August 30th, 2010

  1. DISCUS can export to Medical device manufacturing forms,  governed by 21 CFR Part 820 (and/or ISO 13485) with oversight provided in the US by the Food and Drug Administration (FDA).
  2. Using DISCUS for Part 820 will help you focus on establishing and complying with design requirements.

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Use DISCUS for Characteristic Management

Monday, August 30th, 2010
  1. One of the most time-consuming activities of the PPAP is the effort to identify and document the part’s characteristics. 
  2. Thus, while many software packages for PPAP and APQP focus on document management, DISCUS focuses on Characteristic Management. 
  3. DISCUS helps you to quickly analyze and interrogate the part.
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Data Entry for Variable Data

Wednesday, August 18th, 2010

If you don’t have OCR or if you have an older drawing of poor digital qualilty, you can still expedite your FAI data entry. For example, let’s say the characateristic is 1.24 and the default tolerances are .01.

  1. Under Tools and Default Tolerances enter the default tolerances for two and three places.
  2. After you balloon, open the Characteristic Properties box (looks like a gear). In the first field, enter the value, for example 1.24. Click Evaluate and the value will have the nominal with the upper and lower limits automatically populated from Step 1.
  3. Select the characteristic type from the drop-down box. For Diameter, simply press D and the drop-down populates with Diameter, for example.
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