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Agile Recipe Management for Pharmaceuticals Material Management User Guide Release 9.3.3 E39301-01 |
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# 2 Working with Equipment

The RMW Equipment Library is a repository of equipment master data. It maintains detailed records of the physical and non-physical attributes of each type of equipment. Records are categorized by type for easy search and retrieval.

In the equipment library, you can carry out:

- Equipment Definition management, where you can add, edit, search, duplicate, activate/de-activate, take action, set permission and remove equipment data.

- Equipment Transactions such as Change Site, View Availability, Reserve, Perform Activity, Qualify, Loan and Lease.

You can specify the following when you add a new equipment definition or edit an existing equipment definition in the Equipment Library:

- Cleaning Method - Each type of equipment is associated with one cleaning method. The RMW application allows you to choose one of the following cleaning methods:

  - Dose-in-Dose - the cleaning criteria which is used to calculate the effectiveness of the cleaning.

  - Set Cleaning Limit - the cleaning limit set by you.

You can also choose not to associate a cleaning method.

- Qualification Type - You can specify qualification information to ensure that when such equipment is created in the system, that equipment uses the definition to qualify before usage. Equipment should have at least one qualification associated with it. You can also associate multiple qualifications.

- Accessory List - You can associate accessories like hoses, pipes, etc., to the equipment definition, and thus create an Accessories List for the equipment.

- Equipment Group - Equipment can be grouped for one main reason, namely to enable group reservation. Equipment can also be used to model suites or rooms, where the same transactions (qualify, clean, etc.) are applicable.

Equipment can be grouped to allow users to manage entire rooms for a project. For example: You can create a group "Suite 1" that contains the following:

- Room 1

  - Equip1

  - Equip2

- Room 2

  - Equip3

  - Equip4

When you add group equipment, certain conditions apply. You cannot add equipment in Development mode to equipment in Clinical Supply mode. You can add equipment from the same or a different category to create a group.

Note: The system displays the Group tab between the MOC and Accessories tabs only if a user chooses "Group = Yes" in the General tab.

- MOC - You can specify a Material of Construction (MOC) for the new equipment. Make sure that MOC is specified so that no chemical reaction is caused by the MOC when placing materials in this equipment.

Equipment definitions in a library must be associated with a category. Ensure that the appropriate equipment category is created before you carry out equipment transactions. For information on adding equipment categories, see Agile Recipe Management for Pharmaceuticals Administrator Guide.

## 2.1 Adding New Equipment

Equipment used in any of the recorded processes in RMW must first be entered into the equipment library.

To add new equipment:

1. Go to Create New menu, select Equipment > Library.

2. In the Preface tab, click the arrow next to the Equipment radio button to view sub-categories. Select the category to which the equipment belongs.

3. Click Next.

4. Follow the steps outlined below to create the equipment record in RMW.

### 2.1.1 Step 1: Enter General Information

1. In the General tab, enter required information.

   Significant inputs:

   Equipment Tag Number - The tag number according to which you arrange equipment in your catalog for corporate identification. This could be the ID coming from an Enterprise Asset Management system (EAM), if the Equipment Master is in EAM.
   Current Site - The site ID that currently has the right to use the equipment.

   Product Quality Impact

   - Select Direct, if the equipment has a direct impact on the quality of the product.

   - Select Indirect, if the equipment has an indirect impact on the quality of the product.

   - Select No Impact, if the equipment has no impact on the quality of the product.

   Operating Mode - Indicates the quality operating standards for equipment. Select the operating mode from the drop-down list.

   - Select Clinical Supply, if you are requesting equipment for clinical supplies.

   - Select Development, if you are requesting equipment for development, both experimental and late stage.

   - Select Not Applicable, if you do not wish to associate an operating mode with the request.

     - Effective Start Date - The date from which this equipment becomes active and can be used. You can change this date.

     - Effective End Date - The date on which this equipment becomes inactive and unavailable for use. Leave the field blank if you do not want to specify when this equipment becomes inactive and unavailable for use.

     - Group - Specify whether you want to group other equipment with this equipment.

     - Can Contain Inventoried Material - Select Yes if any material from the inventory is part of this equipment. Certain equipment may store In-process materials, which are being analyzed, sampled etc. For this, the equipment can also be considered as a container. This flag will auto-create a container in the Inventory, which can be used by an analytical scientist to pull in samples.

     Note: When you add a new equipment record to the library, RMW automatically generates an Equipment ID for that record.

2. Click Next.

### 2.1.2 Step 2: Enter Equipment Characteristics

1. In the Characteristics sub-tab under the Details tab, enter required information.

   Significant inputs:

   - Equipment Site - The ID of the site that has the permission to use the equipment.

   - Department - The department that owns the equipment.

   - General Reservation - Indicates if reservation of this equipment should be controlled.

     - Select Yes, if you want to allow general reservation. All users with relevant roles and equipment-reservation rights can hard-reserve equipment.

     - Select No, if you do not want to allow general reservation. Only those users with relevant roles and equipment-reservation rights can hard-reserve equipment.

   Note: See also, information on Equipment Lock Reservation Role, in the Agile Recipe Management for Pharmaceuticals Administrator Guide.

   - Calibration Frequency (in days) - Enter the calibration frequency. This field is enabled only if the Is Calibration Needed field is set to Yes.

   - Allow Simultaneous Activities - Select Yes if equipment can be used for multiple activities simultaneously.

2. Click Next.

### 2.1.3 Step 3: Enter Cleaning and Qualification Details

1. In the Cleaning and Qualification sub-tab under the Details tab, select one of the following cleaning methods:

   - N/A - Select this option if equipment does not require cleaning.

   - Dose-in-Dose - This is the cleaning criteria which are used to calculate the effectiveness of the cleaning. When you select this method of cleaning, the following fields appear:

     - Minimum Lot Size - Refers to the quantity of material that is being used as part of the work request.

     - Final Assay Rinse Vol - Refers to the amount of material (solvent) used as part of the final assay for equipment cleaning.

     - 100 ppm Limit - Refers to how well the equipment needs to be cleaned (i.e. the lowest detection limit for material in question).

     - 10 ppm Limit - Refers to how well the equipment needs to be cleaned (i.e. the lowest detection limit for material in question).

     - Clean Every - Frequency of cleaning.

   - Set Cleaning Limit - Sets a limit for cleaning that suits your process.

   - When you select this method of cleaning, the following field appears:

     - User-defined PPM Limit - The cleaning limit to define the residual amount, in Parts per Million, of the last compound allowed.

2. In the Qualification Types page,

   - Click Add Row(s) to specify the types of qualification checks you would like to perform on the equipment.

   - Select the qualification type for each row that you have added from the drop-down list.

   - Select Installation Qualification, to ensure that the equipment is installed in compliance with the manufacturer's specifications.

   - Select Operational Qualification, to ensure that the equipment operates as intended.

   - Select Performance Qualification, to ensure that the equipment and its associated equipment perform according to approved methods and specifications.

   For more information on qualification, see Working with Equipment Qualification.

   To add more than one qualification check to be performed on the equipment, enter the number of rows in the field adjacent to the Add Rows(s) button and click Add Rows(s). The corresponding number of rows gets added.

   Note: You have to select at least one qualification type to proceed further.

3. Click Next.

### 2.1.4 Step 4: Specify Material of Construction

1. In the MOC sub-tab, click Add to select the Material of Constructionof the equipment from the Results in MOC page. Make your selection and click OK.

2. Select the Material of Construction for the equipment and click OK.

   Note: You can associate one or more materials of construction with the new equipment.

3. If you selected Yes for Group in the General tab, the Group sub-tab appears. Skip to the next step if you selected No.

   1. Click Add to select equipment groups from the Results in Equipment page.

   Selected equipment is added in the Group tab.

   2. From the Group Classification drop-down list, select the category to which you want to associate the equipment.

   3. From the equipment records, select the equipment to be grouped and click Next.

   Note: You can group more than one piece of equipment with the new equipment.

4. If you selected Yes for Can Contain Inventoried Material in the General tab, the Container sub-tab appears. Skip to the next step if you selected No.

   Here, you can specify the details of the container that is used for storing equipment.

   Significant inputs:

   - Status

   - Package Verified - indicates if it has been verified for acceptance or not.

   - Storage Location - search and select.

   - Material of Construction - search and select.

   - Import Status

   - Tare Weight

   - Type - Box, etc.

5. Click Next.

### 2.1.5 Step 5: Add Accessories

In the Accessories sub-tab, you can associate any existing equipment as an accessory to the new equipment.

1. Click Add.

2. From the Results in Equipment page, select the equipment to be added as an accessory. You can add more than one accessory to the new equipment.

3. Click OK. The equipment appears under Name in Accessories.

4. Select one or more pieces of equipment and click Next.

Note: You cannot add any equipment that you have already grouped with the new equipment as accessory equipment.

### 2.1.6 Step 6: Add Consumables

In the Consumables sub-tab, you can add the material that the equipment will use for its operations.

1. Click Add.

2. From the Results in Material page, select the materials to be added as consumables. You can add one or more consumables to the new equipment.

3. Click OK.

4. Select one or more materials as consumables for this equipment.

5. Click Finish.

## 2.2 Interacting with Equipment Objects - the 'More' Menu

Most library objects in RMW have a More button that opens a dropdown list of more actions you can perform on the object. For example, the More > Save As command allows you to duplicate an existing object and modify it to create a new record. The More button is activated when you select an object from the search results.

Actions that you can perform on equipment objects are listed in the table below.

Command | Description
--- | ---
Reserve | Opens the Equipment Reservation page where you can add a reservation for the selected equipment. For details, see Working with Equipment Reservation.
Save As | Enables you to save an existing equipment object under a new name and modify details as appropriate. You can choose to duplicate the Notes and Attachments of the existing record if you wish. To modify any other details, click Save and Edit. Complete your changes and click OK to finish.
Manage Reservation | Opens the Manage Reservation page where you can view or edit existing reservations on the selected equipment, and add new reservations if required. For details, see Working with Equipment Reservation.
Record Activity | Opens the Record Activity page, where you can record one or more activities against the selected equipment. Click Add to add equipment activity. For details, see Adding a New Equipment Activity.
Manage Qualification | Opens the Manage Qualification page, where you can qualify the selected equipment for use. Click Add to create a new equipment qualification. For details, see Adding Equipment Qualification.
Manage Loan/Lease | Opens the Equipment Loan/Lease page where you can loan out or lease in equipment. To loan out the equipment, click New Loan Out. To lease in the equipment, click New Lease In. For details, see Working with Equipment Loan and Lease.
Change Site | Opens the search page where you can search for and select a new site for the equipment. If the equipment loan or lease record is in the status 'In-progress', a warning message appears so that you can check the loan or lease records for the equipment before changing the site.
View Availability | Opens the View Availability page, where the reservation periods, if any, are marked in the calendar. To modify a reservation, click Edit Reservation. If there is no reservation, or if you wish to reserve equipment for a different time period, click New Reservation. For details, see Working with Equipment Reservation.
Activate | Enables you to activate equipment for use. Equipment that is activated can be reserved or modified. Enter the effective start date, effective end date and the reason for activation.
Deactivate | Enables you to deactivate equipment. You cannot deactivate equipment if it is in use or if it is in the reserved state. Enter the effective start date, effective end date and the reason for deactivation.

## 2.3 Changing Equipment Lifecycle Phase

During its lifecycle in RMW, each piece of equipment goes through several 'phases' as part of the process. Users with appropriate privileges can change the lifecycle phase of an equipment object to indicate its current status.

Default status values are described in the table below. Actions that can be performed on an equipment object change according to its status.

Equipment Status | Description | Actions Possible
Hold-QA | On hold till QA releases it for use. | None.
Offline | Not available for use. | Soft reserve, change status, deactivate and manage activity.
Hold-Clean | Undergoing cleaning. On hold till QA releases it for use. | None.
Release To Process | Automatic status assigned when disposition is set during compilation of production BOE. | None
Hold-Maintenance | Undergoing maintenance. On hold till QA releases it for use. | None
Retired | Not available for use in the plant any longer. May have been removed from the plant altogether. | Change status, deactivate and manage activity.
Clean | Cleaning is complete. Not available for edit. | Log activities
In Use | Being used by another user or process. Not available for edit. | None.
Draft | Initial status when created. | Edit, Change Status, Remove, Duplicate, Activate, Deactivate, Manage Reservation, Manage Activity, Manage Qualification, and Manage Loan/Lease.

To change the lifecycle phase of an equipment object:

1. Go to Equipment > Library and run a search.

2. From the search results, select equipment.

3. Click Change > Lifecycle Phase > and select the status you want to assign. The drop-down list in the change status field is filled dynamically. Based on the current status of the equipment, the list is filled with only those statuses to which the equipment can be transitioned.

Note: If an equipment object has a workflow associated with it, only the statuses defined in that workflow will be available for selection.

## 2.4 Recording Activities on Equipment

You can maintain records of all the activities that have been performed on every piece of equipment in RMW. Only completed activities can be recorded. Before use in the production process, the following types of activities are performed on equipment.

- Maintenance - The type of maintenance activity last conducted on the equipment.

- Cleaning - The last cleaning activity, whether major or minor, carried out on the equipment.

- Processing - The lot of material that the piece of equipment was utilized to produce.

- Other - Activities such as setting up and dismantling equipment.

Note: All the activities that are carried out on a piece of equipment must be recorded in order for the equipment to qualify for production or development. Entries that need to be made depend on the type of activity being recorded.

Note: If there is already an activity recorded against a piece of equipment on a particular day or during a particular period, you cannot record a new activity on that equipment for any overlapping day or period.

### 2.4.1 Maintenance Activities

You can record maintenance activity on equipment that is in any status except:

- Release to Process

- In Use

- Retired

Equipment should be qualified and active.

To record maintenance activity on equipment:

1. Go to Create New menu, select Equipment > Activity.

2. In the Preface tab, select Maintenance and click Next.

3. In the General tab, enter required information.

   Significant inputs:

   - Activity Type:

     - Corrective - when you want to fix or repair equipment.

     - Preventative - when you want to check for possible wear and tear in equipment.

     - Calibration - when you want to calibrate equipment as per specifications.

   Note: Equipment that you want to calibrate should have Is Calibration Needed set to Yes. Only a single piece of equipment can be selected for a calibration activity.

   - Change - when you want to make modification to meet new needs or specifications.

   - Start Time - must be prior to the current date as the RMW application records only completed activities.

4. Click Next.

5. In the Characteristics sub-tab under the Details tab, enter required information.

   Significant inputs:

   - Next Scheduled Date - This field does not appear, if the maintenance activity type is Corrective, as it is not possible to reschedule the activity.

   - Change Control Reference Number - The identification of the authorization to make the change to a piece of equipment.

   - Deviation ID - If any deviations from the planned values were found in the activity, enter the corresponding deviation ID.

   - Work Request Number - The number of the work request from where you perform the activity.

6. Click Next.

7. In the Equipment sub-tab under the Details tab, click Add.

8. Select the equipment for which the maintenance activity was performed and click OK.

9. Select the status of each piece of equipment from the Change Status To drop-down list.

   Note: Before you schedule equipment for an activity, ensure that it is Available. If equipment is already scheduled for an activity, the system displays an error message after you click Finish.

10. Click Next.

11. If you selected Calibration for Activity Type under the General tab, the Calibration sub-tab appears.

    Enter the number of rows you wish to add in the field adjacent to Add Row(s).

    - Click Add Row(s).

    - Enter calibration details.

    Note: You can use the Fill Down action to replicate values in columns. For additional tips, see Getting Started with Recipe and Material Workspace.

12. Click Finish.

### 2.4.2 Cleaning Activities

Equipment needs to be cleaned and Available before you can schedule it for an activity.

To record cleaning activity on equipment:

1. Go to Create New menu, select Equipment > Activity.

2. In the Preface tab, select Cleaning.

3. In the General tab, enter required information.

Significant inputs:

- Activity Type

  - Minor - when the cleaning activity is carried out at the equipment site using internal resources.

  - Major-External - when equipment is sent out to an external organization or to another site for cleaning.

1. Click Next.

2. In the Characteristics sub-tab under the Details tab, enter required information.

   Significant inputs:

   - If you selected Minor as the Activity Type in the General tab:

     - Cleaning up after Work Request - Specify the ID of the Work Request that triggered this activity.

     - Boiled Out - Indicates that a boil out has been performed on the equipment.

     - Rinsed - Indicates that a rinse has been performed on the equipment.

     - Visual Check - Indicates that a visual check has been performed on the equipment.

     - Gravimetric - Indicates that a gravimetric test has been performed on the equipment.

     - Gravimetric Comment - Provide comments, specific to the gravimetric test performed.

     - Other - Indicates any other check that has been performed on the equipment.

   - If you selected Major-External as the Activity Type in the General tab:

     - External Batch Record - ID of the batch record that contains the activity instruction details used for re-instating the equipment.

3. Click Next.

4. In Equipment sub-tab under the Details tab, click Add.

5. Select the equipment for which the cleaning activity was performed and click OK.

   Note: You receive a warning message if Equipment Site does not match with Activity Site or if Equipment is in Draft status.

6. Select the status of the equipment from the Change Status To drop-down list.

   Note: Before you schedule equipment for an activity, ensure that it is Available. If equipment is already scheduled for an activity, the system displays an error message after you click Finish.

7. If you selected Minor as the cleaning Activity Sub Type, then click Next. If you selectedMajor-External as the cleaning Activity Sub Type, click Finish.

8. In the Material Used sub-tab under the Details tab, click Add Material.

9. Select the material and click OK.

10. In the in Quantity field, enter the quantity of material used and select the unit of measurement from the drop-down list.

11. Click on Add Contaminant to add a contaminant to the material.

12. Click Finish.

The material or contaminant can be removed by clicking Delete Material. Removing a material, also removes the added contaminants. If the material has more than one contaminant, only the contaminated that you select is removed when you click Delete Material. However, if the material has only one contaminant, both material and contaminant will be removed when you click Delete Material.

### 2.4.3 Processing Activities

To record processing activity on equipment:

1. Go to Create New menu, select Equipment > Activity.

2. In the Preface tab, select Processing and click Next.

3. In the General tab, enter required information.

   - Activity Type

     - External to Agile PLM - is carried out while setting Start Date on BOE Line Item in Work Request for cleaning type of Work Request.

   - Start Time - The time the activity starts. You cannot set a future date.

4. Click Next.

5. In the Characteristics sub-tab under Details tab, enter the information.

   Significant inputs:

   - Material - The material you are processing using equipment.

   - External Lot Number - The identification of the activity instruction details used for re-instating of equipment.

   - Compound Number - The identification number of the compound of the material that was removed while cleaning.

6. Click Next.

7. In Equipment sub-tab under Details tab, click Add.

8. Select equipment for which the processing activity is performed and click OK.

   Note: You cannot select equipment that is in Retired, In-Use, Hold-QA, Hold-Maintenance, Hold-Clean or Offline state.

9. Select the status of equipment from the Change Status To drop-down list.

   The drop-down list in the change status is filled dynamically. Based on the current status of equipment it fills in all the status to which equipment can transition.

   Note: Before you schedule equipment for an activity, ensure that it is Available. If equipment is already scheduled for an activity, the system displays an error message after you click Finish.

10. Click Finish.

### 2.4.4 Other Activities

The Other option is used when the activity is either setting up equipment or dismantling equipment or none of the above.

To add any other activity for equipment:

1. From the Create New menu, select Equipment > Activity.

2. In the Preface tab, select Other and click Next.

3. In the General tab, enter required information.

   Significant inputs:

   - Activity Type:

     - Equipment Setup - if you are setting up new equipment, setting up equipment in a different location, or re-instating equipment.

     - Tear down - if you are removing, un-installing or completely dismantling equipment.

     - N/A - if you are carrying out any activity other than the default activities listed.

   - Transaction Type - Staging is selected by default.

4. Click Next.

5. In the Characteristics sub-tab of the Details tab, enter required information.

   Significant inputs:

   - Material - The material being processed.

   - External Lot Number - The identification of the Lot Number that has the activity instructions used for reinstating equipment.

   - Compound Number - The identification number of the compound used for equipment activity.

6. Click Next.

7. In the Equipment sub-tab of the Details tab, click Add to add equipment on which you are performing an activity.

8. After adding the equipment, select the new status for the equipment from the Change Status To drop-down list.

9. Click Finish.

## 2.5 Removing an Activity Record

While removing an equipment activity record, the significant points to note are:

- No checks are required if the activity being removed is In progress status. Equipment status needs to be reverted to the status it was in before the activity was performed. The status of equipment as part of activity will be changed back to the previous equipment status.

- Equipment removes the activity which is completed, but not the last completed activity, and the status remains unchanged.

- If it is the last completed activity then Status before Activity, Status after Activity and Current Status warnings are shown for the approval, to change the status.

- To change the status of equipment after removing the activity, click OK. To remove the activity without changing the status, click Cancel.

- While removing or editing a Minor or Major External activity, an error message appears stating that these are logged in from a work order and can be modified or removed only from the work order.