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Product Lifecycle Management Agile Recipe Management for Pharmaceuticals - Process Management Guide Release 9.3.3 E39302-01 |
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# 6 Working with Work Requests

A Work Request is a record of all BOP, BOM, BOE, BOS and tests performed to produce a Target Material or a Lot of a particular material. Work Requests are automatically created from Approved Control Recipes or manually from Approved Recipes. Work Requests derived from control recipes, also inherit the material and equipment (which can be modified) associated with it.

There are three types of Work Requests in each phase:

- Cleaning

- Processing

- Other

There are two operating modes for Work Requests:

- Clinical Supply

- Development

Note: Work Requests once created, can only be Aborted or Canceled and not Deleted.

Once a Work Request creates the Output Material, the actual output quantities are displayed in the Work Request, Control Recipe, and Process Step and in the campaign summary at the Project level.

## 6.1 Creating a Work Request

Work Requests are created in two ways:

- From a Recipe

- From an approved Control Recipe.

Note: You can create Work Requests only from ApprovedControl Recipes or Approved Recipes.

To create a work request from a recipe:

1. Go to Recipes > Library and run a search. From the search results, select a Recipe.

2. Go to More> Create Work Request. In the Create Work Request from Recipe page, enter the required information.

   Significant inputs:

   The application automatically creates a Control Recipe from the given recipe, and approves it internally. Operating Mode, Implementation site, Scale Factor Planned Start and End Date.

   - Project - The ID of the project you wish to associate with the work request.

   - Target Quantity - Amount of end product to be produced.

   - Target Yield - Net amount of actual produce expected.

   To create a work request from an approved control recipe:

3. Go to Processes > Control Recipe and run a search. From the search results, select a control recipe.

4. Change the lifecycle phase of the control recipe to 'Approved".

   Once you approve a Control Recipe, RMW generates a Work Request ID associated to that Control Recipe. A message displays the Work Request ID and the Control Recipe it is associated with and also confirms that the Control Recipe is in the Approved status. For example: Work Request ID for Control Recipe 'CR303' is: 'WR53'.

### 6.1.1 Editing a Work Request

Work Requests can be edited when they are in the In Progress status. While editing a Work Request, you can edit the Recipe Action associated with it and also add Material, Equipment or Standards directly to the BOM, BOE or BOS without creating a variable.

## 6.2 Work Request Tabs

The tabs and sub-tabs on the Work Request Details page include:

1. Control Recipe: Lists details of the Control Recipe.

2. Bills of ...: displays the BOP, BOM, BOE, BOA and BOS sub-tabs.

   - Bill Of Process(BOP) - A collection of approved Unit Operations.

     Recipe: Displays associated recipe element and recipe action templates.

     Parameters: Displays the parameters values that were entered and the results.

   - Bill Of Materials (BOM) - A list of materials, which are required to produce the target material of the work request.

     Material: List of material variables.

     Consumables: List of consumable material variables.

     Specification Plan: List of specification plans associated with the work request.

   - Bill Of Equipment (BOE) - List of equipment required / used in the work request Equipment.

   - Bill of Assay (BOA) - List of assays associated with the work request.

   - Bill of Standards (BOS) - List of applicable standards.

     Standards: List of standards applicable to the control recipe.

     Cautions: List of cautions used in the control recipe.

3. Outputs: - List of final material you wish to produce.

4. Notes and Attachments: Notes/attachments providing additional information.

5. History: A detailed account of all events that occurred in the process of making the work request.

   - Status Transition: Lists all the transitions the object undergoes from its initiation.

   - Changes: Records changes that a work request undergoes from its initiation.

   - Workflows: Lists the workflows the work request passes through.

   - Print: Lists print details.

## 6.3 Requesting Inventory from Work Request

You can raise inventory requests for carrying out material transactions from the work request. The process is the same as that for raising requests from a control recipe.

For complete details on how to request inventory, see Requesting Inventory from Control Recipe. Also refer to Recipe & Material Workspace Material Management Guide.

## 6.4 Reserving Equipment from Work Request

You can reserve equipment from a work request. The process is the same as that for reserving equipment from a control recipe.

For complete details on how to reserve equipment, see Reserving Equipment from Control Recipe. Also, refer to Agile Recipe Management for Pharmaceuticals - Equipment Management Guide.

## 6.5 Consuming Inventory from Work Request

You can consume an inventory on ad-hoc basis. This ad-hoc consumption does not require you to carry out any material transactions, that is, requesting material allocation, raising dispense request, staging of material by the material manager, and so forth.

To consume inventory on an ad-hoc basis from work request:

1. Go to Processes > Work Request and run a search. From the search results, select a Work Request.

2. Click More > Consume Inventory.

3. In the General tab, enter the required details.

   Operating Mode - Select one of the modes you are using it for - Clinical, Development, or Not Applicable.

   The Work Request field is automatically populated with the work request ID from which you initiated the consume inventory action.

4. Click Next.

5. In the Containers and Quantities tab, enter the Quantity Consumed and the Consumed Date.

   The Quantity Consumed should not be more than the Quantity on Hand.

6. To add the IDs of additional containers manually from which you wish to consume inventory:

   1. Click Enter Manually.

   2. In the Enter Manually page, enter the Container ID and Quantity to Consume values.

   3. To add more records, click Add Rows and enter the required details.

   4. Click OK to save and return to the Containers and Quantities tab.

7. To add more containers from the inventory records from which you wish to consume inventory:

   1. Click Lookup From Inventory > Entire Inventory.

   2. From the search results, select the Containers and click OK.

8. To delete the containers from which you do not wish to consume any material, select the container records and click Delete.

9. Click Finish.

## 6.6 Recording Parameter Values in Work Request

Results of every parameter defined in the recipe instructions have to be recorded in the RMW application. These results are the actual values of the parameters recorded during the execution of the work request. The Parameters and Results are displayed in a work request that is closed out.

To record the results of a parameter in the work request:

1. Go to Processes > Work Request and run a search.

2. Select a work request from the search results.

3. Click More > Record Parameters.

4. Select a parameter to add a result.

5. Click New Result. In the Results window, enter the required information and click OK.

Significant inputs:

- Recorded Value - The quantity of material and its unit of measurement.

- Test Result - Whether the execution passed or failed the tests, unless not applicable.

- Notebook Reference - The Reference ID of the recording medium.

To edit a record:

1. Select the result record and click Edit Result.

2. Modify the record and click OK.

## 6.7 Adding Material to Inventory

You can add the output material in to the material inventory from the work requests. The output materials are defined in control recipe. These are by-products, secondary products and final target material.

The output materials are defined using the output variables. Resolve the Output variable to Material before you add the output material to the inventory.

To add material to inventory from work request:

1. Go to Processes > Work Request and run a search. From the search results, select a Work Request.

2. Click More > Add To Inventory.

3. Select the output material you wish to add to the material inventory.

4. Click Add To Inventory.

5. In the Lot tab, enter or modify the required information.

   Significant inputs:

   The Add to Inventory action lets you define:

   - Target Material Lot - Target Material Lot number is auto generated Number by default. You can change it to Manual Entry and assign a new Lot number, manually.

   - Number of Containers - This field is automatically populated by the application, however, you can change this value.

   - Quantity - Specify the amount of output material and its applicable unit of measurement.

   - Final Form - Select Yes if the output material is in its final form.

   - Crystal Form - The form of the material, whether it is in crystals.

   - Stability Study - Select Yes if any stability study was carried out on the material. If you select No, you will need to enter details in the Reason Not On Stability.

6. Click Next.

7. In the Containers tab, enter or modify the required information. You can enter the details of the container in which you wish to store the output material.

   Significant inputs:

   - Container ID - Generated by the application.

   - MOC - Selects the material of construction of the container.

   - Container Size - Overall capacity of the container in volume units.

   - Container Type - Selects the shape of the container.

   - Gross Quantity - Total Weight (mass) of the material and container, including packing.

   - Net Quantity - Weight of the material in the container. This is equal to the difference of gross weight and tare weight.

   - Tare Quantity - Mass of an empty container including all fittings and appliances associated with that particular type of container on its normal operating condition.

   - Storage Location - The location of the container to store the output material. This field is mandatory.

8. Click Finish.

## 6.8 Recording Equipment Activity from Work Request

Resolve the equipment variables in BOE to specific equipment from the library. In record Activity, set the Start Time, End Time and the equipment Status after Activity. You can also delete the activities from the list.

To record the equipment activity from a work request:

1. Go to Processes > Work Request and run a search. From the search results select a Work Request.

2. Click More > Record Activity.

3. In the Record Activity page, change the Start Time and End Time to the actual recorded activity times.

4. Select the new status of the equipment from Status after Activity.

5. To delete an equipment activity record, select the desired row and click Delete.

6. Click OK.

## 6.9 Viewing Equipment Usage from Work Request

At any time during the execution of a work request, you can view equipment related activities.

To view equipment usage from a work request:

1. Go to Processes > Work Request and run a search. From the search results, select a Work Request.

2. Click More > View Equipment Use.

A table displays the list of equipment and recorded activities.

## 6.10 Auditing Closeout of Work Request

Before you closeout a work request, you need to audit if the objects in the work request encountered any problems during execution. You cannot close a work request until all the exceptions are resolved. It can be due to various reasons; the variables and parameters that you defined in recipe action template were not resolved to any objects from the library; a container status remains "to be evaluated", and so forth.

The Audit Closeout action in RMW allows you to see the problems that objects encountered before creation of a work request.

To audit a work request for closeout:

1. Go to Processes > Work Request and run a search. From the search results select a Work Request.

2. Click More > Audit Closeout.

A table lists objects and describes the problems encountered.

## 6.11 Closing Out a Work Request

After you execute the work request and production is complete, you can Close Out the work request. 'Closing out' a work request is possible when its lifecycle phase is In Process. Ensure to generate a lot number for the work request before you close out the record.

To close out a work request:

1. Go to Processes > Work Request and run a search. Select the work request you want to close out from the search results.

2. Click More >Close Out.

3. Enter the required information.

   Significant inputs:

   - Production Status - indicates whether the work request was successfully Finished or Aborted because of failures.

   - Target Material Was Produced - indicates whether the target material was successfully produced or not.

   - Lot Release Process - select the process used for releasing the final Lot.

   Note: A table lists exceptions associated with the objects in the work request, below the close out form.

4. Click OK.

## 6.12 Changing Lifecycle Phases of Work Requests

You can change the status for a Work Request manually or through a workflow. A Work Request has the following lifecycle phases:

- Canceled: when the work request is not in use.

- In Progress: when the work request is in use.

- Completed: when the work request is executed.

To change the lifecycle phase of a work request manually:

1. Go to Processes > Work Request and run a search. From the search results, select a work request.

2. Click Change > Lifecycle Phase and select the applicable lifecycle phase.