DISCUS Blog

DISCUS for 21 CFR Part 820

rkeller — Mon, 30 Aug 2010 19:26:31 +0000

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).

Using DISCUS for Part 820 will help you focus on establishing and complying with design requirements.

Use DISCUS for Characterstic Management

rkeller — Mon, 30 Aug 2010 19:11:05 +0000

One of the most time-consuming activities of the PPAP is the effort to identify and document the part’s characteristics.
Thus, while many software packages for PPAP and APQP focus on document management, DISCUS focuses on Characteristic Management.
DISCUS helps you to quickly analyze and interrogate the part.

Data Entry for Variable Data

rkeller — Wed, 18 Aug 2010 21:13:38 +0000

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.

Under Tools and Default Tolerances enter the default tolerances for two and three places.
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.
Select the characteristic type from the drop-down box. For Diameter, simply press D and the drop-down populates with Diameter, for example.

Check out Tracking of Results

rkeller — Thu, 29 Jul 2010 15:37:46 +0000

If you want to know who entered the result and the time, you can do so easily.

In the Results Characteristics Properties box, click the Tracking tab.
The user name of the person who created the characteristic and the person who entered the result display. The date and time of the result entry are also recorded.

Add Specs to Form 2 Via Notes

rkeller — Thu, 29 Jul 2010 15:27:19 +0000

When specifications and processes are called out in notes, you can easily add them to Form 2.

Balloon the note. With OCR, drop, drag the item.
When finished, click the characteristic and the Characteristics Properties icon (looks like a gear in the BoC).
Highlight the spec or process name and right click.
Select the Add Spec and complete the data in the box that displays.
When you export the Boc, the spec and/or process name is included in Form 2.

Enter Ranges and Multiple Results

rkeller — Wed, 28 Jul 2010 15:36:50 +0000

When entering results in the DISCUS Results module, you can enter ranges and multiple values.

For a range, enter the lower and upper limit, separated by a hyphen, such as, 1.25-1.27.
For multiples, enter the numeric value separated by a comma, such as, 1.25, 1.26, 1.27.
Each item is validated and the worst-case is reported as failing or warning.
Click the Multiple Results button to review the individual status of each entered result.

Where did the word DISCUS come from?

admin — Thu, 15 Jul 2010 13:35:44 +0000

Believe it or not, DISCUS is an acronym. It stands for Dynamic Interactive System for Characteristic Utilization and Selection. Whew!!!

Key in on Key Characteristics

rkeller — Wed, 30 Jun 2010 20:33:26 +0000

To make a Key Characteristic stand out on the drawing, use any of these tips:

Change the Key Characteristic balloon shape under File and Balloon Properties.
Enlarge the size in the Balloon Properties box.
Fill in the balloon shape.
Add a Key Designator, such as *.
When you export, the Key will be dramatically apparent.

Zoom with Space Key

rkeller — Wed, 30 Jun 2010 20:27:59 +0000

Navigate the zoom with the space key.

Use the zoom tool to initially zoom into an area.
Press the Space bar and keep it depressed.
Click the left mouse to move the zoom throughout your drawing.
When you find a location to view, let go of the Space bar.
Repeat 2-4 as needed

Remove Drawings and Specs

rkeller — Wed, 30 Jun 2010 20:24:14 +0000

If you add a drawing and need to remove it, do so easily. No balloons can be associated to the drawing, however.

Click File and Bill of Documents.
Select the item you want to remove and click the X icon.
The document is removed from the TDP.