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Published by Articulate® Storyline www.articulate.com PLM105 Artwork 1. PLM105 Artwork 1.1 Design Control Procedure - Artwork Notes: Welcome to the Design Control Procedure - Controlled Artwork course.

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Page 1: PLM105 Artwork 1. PLM105 Artwork

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PLM105 Artwork

1. PLM105 Artwork

1.1 Design Control Procedure - Artwork

Notes:

Welcome to the Design Control Procedure - Controlled Artwork course.

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1.2 Objectives

Notes:

At the end of this course, you will be able to:

Explain how Controlled Artwork Design fits into the Applied Business process

Explain key Controlled Artwork Design terms and definitions

Explain how Controlled Artwork requests and documents are added to the ER

Create, change, review, and approve Controlled Artwork requests

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1.3 Controlled Artwork

Notes:

Controlled Artwork: Artwork printed on product labels, boxes, and pouches, that are tracked and protected through the document control process.

Two documents are used to track Controlled Artwork: Artwork Requests and ART Documents. After each document is completed, they are submitted and approved on their own DIR in an ER.

Examples of controlled artwork are, Pouch labels and Artwork, Box labels and Artwork, Instructions for Use or IFUs, manuals, Incision Templates, printing Plates, and Supplier Apps

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Examples (Slide Layer)

1.4 ARQ Documents

Notes:

The ARQ Document is the Artwork Request form. It is used for both new artwork requests (major changes) and for changes to existing artwork (minor changes). It is filled out by the project lead/originator and processed through NWBC Workflow.

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1.5 ARQ Document Status

Notes:

At any given time, an ARQ will have one of five statuses. Click the statuses on the left to learn more about each one.

In Work (Slide Layer)

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Request Review (Slide Layer)

Completed (Slide Layer)

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Canceled (Slide Layer)

Request Approved (Slide Layer)

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1.6 ART Document

Notes:

The second document used for Controlled Artwork is the ART document. This document is filled out by Branding based on the information provided in the ARQ. Each request in an ARQ is then converted to its own ART document. Once the ARTs are complete, they are sent through the workflow approval process and attached to the ER.

1.7 ART Document Status

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Notes:

An ART document will always have one of four statuses. Click the different statuses on the left to learn more about each one.

In Work (Slide Layer)

Final Review (Slide Layer)

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First Article Inspection (Slide Layer)

Approved (Slide Layer)

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1.8 ARQ and ART Process

Notes:

This is the process flow for ARQ and ART Docs. Please click on each process to learn more.

The artwork requestor creates an ARQ. A single ARQ may include requests for more than one item.

The ARQ status is "Request Review." The initiator's department manager as well as regulatory reviews it through the NWBC. The manager and regulatory must approve the ARQ before it can be forwarded to Branding.

The ARQ status is "Request Approved." Branding Manager receives the ARQ through NWBC and reviews it.

The Branding Manager creates ART docs for each item listed on the ARQ.

When creating the ART docs, the Branding manager fills out as much information as possible, including characteristics, model numbers, and whether it is a major or minor change.

The ART status is "In Work." The Branding team member receives a process route notification, alerting them to their assignment. They create the artwork and fill out the ART document.

Once all of the items on the ARQ are complete, the generated artwork is attached to the ART doc.

All assigned approvers (including the Initial Requestor) review and approve the ART docs using NWBC Workflow.

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The ARQ status is set to 'Complete.'

Creates ARQ (Slide Layer)

ARQ Review (Slide Layer)

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ARQ Approved (Slide Layer)

Branding creates ARTs (Slide Layer)

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Create Artwork (Slide Layer)

ARQ Complete (Slide Layer)

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1.9 Menu

Notes:

This is the course menu. Please start at the top, and click each topic to learn the ARQ and ART process.

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2. ARQ Creation

2.1 Create an ARQ

Notes:

To request controlled artwork, the project lead/initiator must create an ARQ using the Create a Document process in NWBC.

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2.2 Click the text box

Notes:

Once you have completed the ARQ request form provided by the branding team, you will need to create an ARQ doc in NWBC.

Open the Product Engineering Menu

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2.3 Click the text box

Notes:

Open the Document Menu

2.4 Click the Create Document link

Notes:

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Click Create Document

2.5 Click the text box

Notes:

Enter the document type.

In this example we are creating an ARQ doc

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2.6 Click the Continue link

Notes:

Click Continue

2.7 Click the text box

Notes:

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Enter the Document description

2.8 Type ARQ: Request Approva

2.9 Click the Add Original link

Notes:

Click add original to attach the completed ARQ form

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2.10 Click the Browse... link

Notes:

Follow these steps to attach the file

2.11 Click Choose file

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2.12 Click Choose file

2.13 Click the OK link

Notes:

Click Ok

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2.14 Click the text box

Notes:

Select the application type for the attached document

2.15 Click the OK link

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2.16 Click the text box

Notes:

Select the document we just attached

2.17 Click the link

Notes:

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Click Check in. you will notice the lock icon goes from unlocked to locked once the document is checked in

2.18 Click the cell

2.19 Click the text box

Notes:

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Open the Characteristics tab

2.20 Click the text box

Notes:

Open the Class drop down menu

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2.21 Click the image

Notes:

Here we will select the change level of ARQ document we are submitting.

Please see SOP 1-0104 for more information on major and minor changes.

2.22 Click the OK link

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2.23 Click the text box

Notes:

Open the reviewers/ notes tab

2.24 Click the Add Reviewer link

Notes:

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Please refer to the Approval Matrix Charts when adding reviewers. For more information regarding these Charts, please see SOP 1-0104.

Add reviewers to the ARQ,

We will be adding two reviewers, Review requestor and Branding Manager

2.25 Click the cell

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2.26 Click the text box

2.27 Type rjoshi

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2.28 Click the group

2.29 Click the cell

Notes:

The Branding Manager will always be added as a reviewer so that both the reviewers and branding manager are in agreement of the redlines before work begins.

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2.30 Click the text box

2.31 Type Branding Manager's Name

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2.32 Click the Check Entries link

Notes:

Click Check entries

2.33 Click the Save Document Number link

Notes:

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Verify Entry validation, and click save

2.34 Click the text box

Notes:

Return to the General Data tab

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2.35 Click the text box

Notes:

At this point we are going to update the document status from in work to request review

2.36 Click the table

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2.37 Click the Save Document Number link

Notes:

Click save

2.38 Click the Read Only link

Notes:

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This is the end of the creating an ARQ document simulation

3. Create ART Shell DIR

3.1 Create an ART Document

Notes:

The Branding Manager creates an ART doc for every artwork requested in the ARQ. Each ART is assigned to a Branding Team Member.

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3.2 Click the Index pane

Notes:

This simulation will review the branding manager creating an ART document shell which included entering as much information as possible, assigning reviewers, and starting a process flow to assign this document to a member of the branding team.

Expand the Product Engineering Menu

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3.3 Click the PLM Control Center link

Notes:

Open the PLM Control Center

3.4 Click the group

Notes:

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Select a workflow item to Execute

3.5 Click the Execute link

Notes:

Click Execute

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3.6 Click the link

Notes:

Open and review the attached ARQ

3.7 Click and drag

Notes:

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Review the ARQ document. For each request in this document, the branding manager will create 1 ART doc

3.8 Click the Close button

Notes:

Once you have reviewed the document, close the PDF

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3.9 Click the Index label

Notes:

Return to the NWBC Index page

3.10 Click the text box

Notes:

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Expand the Engineering Record menu

3.11 Click the Change Engineering Record link

Notes:

Click Change Engineering Record

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3.12 Click the text box

Notes:

Enter the engineering record number, and click continue

3.13 Type 30030400

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3.14 Click the Continue link

3.15 Click the text box

Notes:

Click the documents tab

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3.16 Click the You can also link

Notes:

Click 'You can Also'

3.17 Click the text box

Notes:

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Click Create Document

3.18 Click the text box

Notes:

Enter the Document type, we are creating an ART doc

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3.19 Type art

3.20 Click the Continue link

Notes:

Click Continue

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3.21 Click the text box

Notes:

Enter the document description

3.22 Type ART Document

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3.23 Click the Add Original link

Notes:

Now we will link our art doc back to original ARQ document.

Click Object Links

3.24 Click the Add Object link

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Notes:

Click add Objects

3.25 Click the group

Notes:

Select the Object type you are adding, and click ok

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3.26 Click the OK link

3.27 Click the text box

Notes:

Enter the document information

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3.28 Type 17495

3.29 Type ARQ

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3.30 Type 000

3.31 Type 01

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3.32 Click the text box

Notes:

Open the Characteristics tab

3.33 Click the text box

Notes:

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Enter the category information for the document

3.34 Click the cell

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Notes:

select the type of ART doc the team member will be creating

3.35 Click the OK link

Notes:

Click OK

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3.36 Click the text box

Notes:

Click Class

3.37 Click the image

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Notes:

Here we are identifying if the ART doc will be a new or Major change or if the ART doc is an update or Minor Change

3.38 Click the OK link

Notes:

Click ok

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3.39 Click the text box

Notes:

When assigning characteristics to your document, it is important to fill out the Model number field. The regulatory team searches for documents by model number. With this field filled out, the Regulatory team will be able to pull all documents related to a technical file

Next we will add reviewers to our document.

Open the Reviewers/Notes tab

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3.40 Click the cell

3.41 Click the cell

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3.42 Click the cell

3.43 Click the text box

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3.44 Type rjoshi

3.45 Click the Add Reviewer link

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3.46 Click the cell

3.47 Click the text box

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3.48 Click the text box

3.49 Type cst

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3.50 Click the text box

3.51 Click the Add Reviewer link

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3.52 Click the group

3.53 Click the text box

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3.54 Click the text box

3.55 Type rjos

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3.56 Click the text box

3.57 Click the Add Reviewer link

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3.58 Click the group

3.59 Click the cell

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3.60 Click the text box

3.61 Type ts

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3.62 Click the text box

3.63 Click the Save Document Number link

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3.64 Click the text box

Notes:

Open the Process Route tab

3.65 Click the Add Sequential Task link

Notes:

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Click add sequential task to assign this ART doc to a member of the branding team.

3.66 Click the cell

Notes:

Select SAP user to assign a process route to an applied team member

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3.67 Click the text box

3.68 Click the text box

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3.69 Click the text box

Notes:

When assigning the "Activity", be sure to select "Assign" when assigning it to a Branding "artist" Team Member. Select "review" if the Branding Manager wants to be notified when the artist is done.

In this simulation, we are selecting "review".

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3.70 Click the text box

Notes:

Set the Task Priority

3.71 Click the text box

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3.72 Click the OK link

Notes:

Click OK

3.73 Click the Save Document Number link

Notes:

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Click Save

3.74 Click the Start Workflow link

Notes:

Highlight the line item, and click start Workflow. This will kick off the process route and send this item to the branding team members process route inbox.

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3.75 Click the Save Document Number link

Notes:

Click save

3.76 Click the Read Only link

Notes:

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Click Read Only

3.77 Click the Refresh link

Notes:

Click refresh, and verify the update of the status column

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3.78 Click the cell

4. Add File to ART DIR

4.1 Add a File to an ART DIR

Notes:

Once the Controlled Artwork is created, the artwork documents are attached to the ART.

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4.2 Click the text box

Notes:

This simulation will show the branding team member review the assigned process route of the ART, attaching the artwork files to the ART and starting the workflow review process.

Expand the Product Engineering Menu

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4.3 Click the PLM Control Center link

Notes:

Click the PLM Control center

4.4 Click the Process Routing: Work Item (1) belonging to type Process

Routing Inbox: Work Item link

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Notes:

Click Process Routing Inbox

4.5 Click the group

Notes:

Select the Process Route Line item

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4.6 Click the Execute link

Notes:

Click Execute

4.7 Click the text box

Notes:

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Click the Objects link tab

4.8 Click the text box

Notes:

Open the Object links type drop down

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4.9 Click the cell

Notes:

Select the Document Info Record

4.10 Click the link

Notes:

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Click the document link to review the ARQ

4.11 Click the link

Notes:

Open the PDF to review the ARQ and understand the requirements for your artwork

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4.12 Click and drag

Notes:

review the ARQ

4.13 Click the Close button

Notes:

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Close the Document

4.14 Click the Edit Document Number link

Notes:

After you have created the requested artwork, return to the NWBC. Display the ART doc and click edit.

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4.15 Click the Add Original link

Notes:

Click Add original to attach the artwork you have created. You will need to attach both the native artwork file, and a PDF version for easy viewing

4.16 Click the Browse... link

Notes:

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Click Browse to search for and attach your files

4.17 Click Choose file

4.18 Click Choose file

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4.19 Click the OK link

Notes:

once you have found your file, click OK

4.20 Click the group

Notes:

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Select the document type

4.21 Click the OK link

4.22 Click the group

Notes:

You will need to check in each item individually. Select the line item

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4.23 Click the Check In link

Notes:

Click Check in

4.24 Click the text box

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Notes:

Click Check in, and notice that the icon in the status icon, changes from unlocked to locked

4.25 Click the Add Original link

Notes:

add additional documents as needed

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4.26 Click the Browse... link

4.27 Click Choose file

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4.28 Click Choose file

4.29 Click the OK link

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4.30 Click the group

Notes:

Make sure you check in the newly added document

4.31 Click the link

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4.32 Click the text box

4.33 Click the Save Document Number link

Notes:

Click Save

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4.34 Click the text box

Notes:

Verify the save message. Open the document status menu from 'In Work' to Final Review.

This will kick off the workflow of the reviewers that the Branding managers assigned to the ART doc

4.35 Click the text box

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4.36 Click the Save Document Number link

Notes:

Click Save and Return to the Work Center

4.37 Click the text box

Notes:

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As a Branding Team Member you need to mark your task complete for the Branding Manager by using the e-signature on the Process Route.

Select the item you just saved

4.38 Click the Complete link

Notes:

Click complete, this will prompt you to enter your e-signature

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4.39 Click the Digital Signatures for Process Route pane

Notes:

Expand the signature window

4.40 Click the text box

Notes:

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Enter your NWBC log on information to sign the document

4.41 Type password

4.42 Click the text box

Notes:

Enter any comments as needed

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4.43 Type File added to ART DIR

4.44 Click the Sign link

Notes:

Click Sign

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4.45 Click the image

Notes:

Verify that the signature was accepted, and return to the work center tab

4.46 Click the Refresh Current Query link

Notes:

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Click refresh

4.47 Click the Change Document: 17497 label

Notes:

Verify that the Line item has moved out of your inbox.

Return to the Change document tab

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4.48 Click the text box

Notes:

Verify that the Status icon has changed, and the document status reflects Completed

4.49 Click the table

Notes:

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This is the end of the simulation

5. Completed ARQ2

5.1 Completed ARQ

Notes:

Once all of the artwork requested in the ARQ is complete and approved, the status of the ARQ is changed to 'Complete.'

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5.2 Click the cell

Notes:

This simulation will review the process of closing out the approved ARQ once the branding manager receives an alert that the ART document has completed the workflow process.

From your work center inbox, select the ARQ item that is associated with the ART document you received the approval notice for

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5.3 Click the Execute link

Notes:

Click Execute

5.4 Click the text box

Notes:

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Open the object links tab to view the associated ART doc

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5.5 Click the text box

Notes:

Open the Object Link Type drop down

5.6 Click the cell

Notes:

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Select 'Document Information Record'

5.7 Click the link

Notes:

Click the document number link

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5.8 Click the text box

Notes:

Open the status tab

5.9 Click and drag

Notes:

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Review the list of statuses that the document has moved through

5.10 Click the text box

Notes:

Open the Process Route Tab

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5.11 Click the text box

Notes:

Ensure that the process route has been completed.

Once you are done reviewing the process route, return to the General Data tab

5.12 Click the image

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Notes:

Close the Document Window

5.13 Click the text box

Notes:

Return to the General tab for the ARQ document

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5.14 Click the text box

Notes:

Update the Document status to 'Completed'

5.15 Click the cell

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5.16 Click the Save Document Number link

Notes:

Click Save

5.17 Click the image

Notes:

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Close the document window

5.18 Click the Refresh Current Query link

Notes:

Click 'Refresh' and confirm that the ARQ item has left your inbox.

This is the end of the simulation

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6. Summary

6.1 Summary

Notes:

You have completed the SAP Artwork course. You should now know how the Controlled Artwork Design fits into the Applied Business process. You should also know key Controlled Artwork Design terms and definitions, as well as how to explain how Controlled Artwork requests and documents are added to the ER. You should also be able to create, change, review, and approve Controlled Artwork requests.

Click on Review Course to return to the main menu and review any part of the course. If you are ready to take the quiz, click on "Take Quiz".