Controlled Printing

Purpose

Learn how to:

Use the Controlled and Uncontrolled Printing features

Expected Outcome

Users are equipped to handle Controlled Printing in SimplerQMS

Prerequisites for all

• Must be logged in to SimplerQMS
• Must be a member of one of these ‘User Groups’ to view and print records:
  • All internal and external users
• Must be a member of one of these ‘User Groups’ to create new records
  • All Contributors

Section 1: Workflow overview

The flowchart below outlines the workflow of Controlled and Uncontrolled Prints.

Section 2: Printing Prerequisites

Controlled Printing in SimplerQMS allows users to generate controlled and uncontrolled prints of documents, and track, manage, and recall documents that have been printed.

The difference between Controlled and Uncontrolled Prints:

• Controlled Prints are all copies that you keep within your control, such as printed copies on a production floor, office, or storage.
  • These copies can be recalled on demand or will be recalled automatically when a new version of the document / template is released. Learn more about recalled prints in step 3.3
• Uncontrolled Prints are for occasion when you need a copy of a document that will be deemed invalid within 24 hours. This would be useful in the case of inspections temporary sharing, and meetings.

For this feature to work, you will need to request the SimplerQMS team to enable the feature in your production vault. If you are unsure if this feature is right for you, please consult with your implementation lead for further details and access to the training environment where the feature could be demoed and tried.

When the configuration is completed by the SimplerQMS team, you will need to provide details if the controlled printing module should be applied to:

• Templates
  • If controlled printing is turned on for templates, all templates will be blocked from normal printing and will always require you to use the Print/Download dashboard to retrieve a print/copy from the system.
• Quality Documents
  • If controlled printing is turned on for quality documents, you will need to make an individual assessment on all your document types to determine which ones will or will not require controlled printing via the Print / Download dashboard. This is the job of any user with the Metadata Administrator role.

Once the module is enabled, when you open a PDF Effective copy of a document / template printing will be blocked:

Note: Paid PDF Processing software can override the controlled printing encryption. This means that printing will be allowed even if the module is turned on.

Quality Document – Document Type Settings

A quality document will require Controlled Printing if the selected document type is defined to require Controlled Printing. Both Controlled and  Uncontrolled Prints are controlled by this value on the Document Type Metadata.

ONLY a Metadata Administrator can create and configure the Document Type.

In this example, the WI document type requires Controlled Printing.

This means that opening the effective version of any document on this document type will not allow regular printing. Instead to print this document the Print/Download Dashboard will need to be used.

In this example, the Manual document type does not require Controlled Printing. This means that opening the effective version of any document on this document type will allow regular printing of the document.

Documents with and without requirements for controlled printing can coexist in your system, so you can control only those that really need it and allow free printing of others.

Section 3: Controlled Prints

Any user with the All Contributors User Group and access to released copies of documents / templates can initiate controlled prints.

Step 3.1 – Create a Controlled Print – Print Initiator

I. Locate the effective copy of the document / template you wish to print.

II. Under Print Actions, click on Print/Download.

The Printout Item Dashboard will be presented.

III. Ensure that the selected print type is Controlled Print

IV. Provide a Reason for printing.

V. Click on Create New Printout Item and wait for your print to generate.

Step 3.2 – Opening and printing the printout – Print Initiator

Once the Printout has generated, a link will be available to open inside the dashboard:

I. Click on the link and wait for the document to load. Most PDF Processing software will open directly to the Print layout.

II. Verify that the correct watermark is present in the footer of the printout created.

III. Once you are ready and connected to a printer, print the document, then close the PDF

IV. If successful, mark your print as Success in the print dashboard. It will no longer be possible to open the link once you have marked it as successful.

a. If your printing failed due to any interruptions (no printer paper, no ink) mark it as a failure.

V. If you already closed the dashboard, locate the Controlled Print Document Tracking Item as described in the next step.

Step 3.3 – Controlled Print Document Tracking Item – Print Initiator

Every printout will generate a new tracking item. The tracking item is used to ensure traceability of all printouts via their unique ID.

Controlled Print titles will always include the abbreviation CP and the print ID. To have an overview of all controlled print tracking items, navigate to Masterdata Views > Prints > Controlled Print Items.

Unless you have already marked the printout item of the print you generated as Success or Failure in the dashboard, the Tracking Item should be assigned to you in state “Available for Printing”. You also receive an email notification about the pending item. This ensures that no tracking item is forgotten.

You can also locate it by expanding on the Effective document version that you initiated the printout from, then expanding on Controlled Tracking Items.

The tracking item metadata stores important details of your printout. You do not have the option to modify the tracking item metadata.

Follow the steps outlined in the Assignment Description:

I. Click on the Tracking Item.

II. Under State Transition select Print Successful.

a. If your printing failed due to any interruptions (no printer paper, no ink) mark it as Print Failed.

Note: If a tracking item is left in the “Available for Printing” state, the system will treat it as a Successful print when the original document (version) is recalled.

Step 3.4 – Information stored on the Tracking Item Metadata

Step 3.5 – Recalling Printouts

When a new version of the printed document is released, controlled printouts are recalled automatically. However, at any point in the document’s lifetime the responsible person of the document or the process manager of the process the document is currently on can decide to recall the printout(s) for the document.

Option 1: Automatic Recall – System

When a new version of a quality document or template is released and effective, the associated printouts will automatically get recalled since the printed version is no longer effective. All associated Document Tracking Items will be assigned to the users who printed them to get destroyed with a due date of 2 business days.

Note: On automatic recalls, the “Recalled By” field of the metadata will stay empty.

Option 2: Manual Recall – Responsible Person

The recall can be initiated by the responsible person of the original document manually. To initiate a recall:

I. Locate the print item you wish to recall as RP of the original document.

a. Navigate to the document, then expand using the arrow on the site and locate the print tracking item.

II. Click on Recall under state transition.

a. You can also send a recall notification prior to recalling the document, to notify the user who printed the document about an upcoming recall.

b. Destroy is also an option for the Responsible Person of the original document in case they have collected the copy and destroyed it themselves.

III. Once Recalled, the information relating to recall will be filled on the metadata:

Step 3.6 – Handling Recalled Prints – Print Initiator

Regardless if manual or automatic recall has been initiated, the printed copy created by the user who printed it will need to be destroyed. Please consult your procedures around controlled prints to take appropriate action on the physical printout you created once it has been recalled.

Recalled print tracking items will be present in the Assigned view of the person who printed them, and an email notification will also be sent. The system allows for 2 business days as a due date for completing this action:

Once you receive a notification about a recalled controlled printout:

I. Handle the printout according to procedure.

II. Locate the print item inside SimplerQMS.

III. Click on Destroyed under State Transition.

Once Destroyed, the User who destroyed the print and the date of destruction will be captured on the metadata:

Note: After the Due Date is passed, the controlled print items will go on Recall Overdue. Ensure that it is handled immediately. Responsible Person of the original document will also be notified of an overdue recall and the system will capture it the destruction didn’t happen on time.

Section 4: Uncontrolled Prints

Any user with the All Contributors User Group and access to released copies of documents / templates can initiate uncontrolled prints.

Step 4.1 – Create an Uncontrolled Print – Print Initiator

I. Locate the effective copy of the document / template you wish to print.

II. Under Print Actions, click on Print/Download

The Printout Item Dashboard will be presented.

III. Ensure that the selected print type is Uncontrolled Print (Reference doc. with copy watermark).

IV. Provide a Reason for printing.

V. Click on Create New Printout Item and wait for your print to generate.

Step 4.2 – Opening and printing the printout

Once the Printout has generated, a link will be available to open inside the dashboard:

I. Click on the link and wait for the document to load. Most PDF Processing software will open directly to the Print layout.

II. Verify that the correct watermark is present in the header and footer of the printout created.

a. Header:

b. Footer:

III.Once you are ready and connected to a printer, print or save the document, then close the PDF.

IV. If successful, mark your print as Success in the print dashboard. It will no longer be possible to open the link once you have marked it as successful.

a. If your printing failed due to any interruptions (no printer paper, no ink) mark it as a failure.

V. If you already closed the dashboard, locate the Uncontrolled Print Document Tracking Item as described in the next step.

Step 4.3 – Uncontrolled Print Document Tracking Item – Initiator

Every printout will generate a new tracking item. The tracking item is used to ensure traceability of all printouts via their unique ID. Uncontrolled Print titles will always include the abbreviation CP and the print ID.

To have an overview of all controlled print tracking items, navigate to Masterdata Views > Prints > Uncontrolled Print Items

Unless you have already marked the printout item of the print you generated as Success or Failure in the dashboard, the Tracking Item should be assigned to you in state “Available for Printing”. You also receive an email notification about the pending item. This ensures that no tracking item is forgotten.

You can also locate it by expanding on the Effective document version that you initiated the printout from, then expanding on Controlled Tracking Items.

The tracking item metadata stores important details of your printout. You do not have the option to modify the tracking item metadata.

Follow the steps outlined in the Assignment Description:

VI. Click on the Tracking Item.

VII. Under State Transition select Print Successful.

a. If your printing failed due to any interruptions (no printer paper, no ink) mark it as Print Failed.

Note: If a tracking item is left in the “Available for Printing” state, the system will treat it as a Successful print when a new document version is created.

Step 4.4 – Information stored on the Tracking Item Metadata

Step 4.5 – Archiving Uncontrolled Prints – Print Initiator

When the uncontrolled printout expires it should be archived or handled according to your procedures.

Archiving a printout is always available for the Print Initiator and the Responsible Person of the original document / template. Uncontrolled Print Items will be automatically archived once the original document is released on a new version.

To manually archive an uncontrolled print:

I. Click on the uncontrolled print tracking item.

II. Click Archive under State Transition.