Learn how to:
- Manage Product Item implementation in SimplerQMS with Change Request
- Users are equipped to handle Change Requests for Product Items in SimplerQMS
- All new Product Items and Product Item updates are implemented by creating a Change Request
Prerequisites for all
- Must be logged in to SimplerQMS version 2.8
- Must be a member of one of these ‘User Groups’ to view records:
- All internal and external users
- Must be a member of one of these ‘User Groups’ to create new records
- All Contributors
Prerequisites for creating Product Items
- Must be a member of one of these ‘User Groups’
- Product Manager
Prerequisites for creating Change Request
- Change Manager
Section 1: Product Item requirements
Product Items created in SimplerQMS are always required to run under a Change Request. This has 3 implications:
- After a Product Item is created, it will not get released until you have completed the Change Request process.
- When Product Items are added to a Change Request for updates, the Product Item data will not become editable. When running an update, include Product Items only when there is Product Item documentation involved in the Change Request. If you wish to make changes to a Product Item, it is recommended that you retire old Product Items and replace them by a new one.
- Retirement of Product Items is controlled by Change Request.
This Work Instruction outlines the creation process of Product Items. To find the relevant steps for Change Request, refer to Work Instruction: Managing Change Request.
Section 2: Creating a Product Item – Product Manager
Step 2.1 – Create a Product Item
The person to create a Product Item in SimplerQMS must be a member of the Product Manager User Group.
There are multiple ways to create a Product Item in SimplerQMS:
I. In the Create New section, on your Home Tab, click on Product
ii. Click on the Create (+) next to the Home Tab and choose Product from the dropdown list
iii. On the right side of the screen, expand Create and click on Product
A Metadata Card will pop up.
Step 2.2 – Fill in the Metadata Card
Part 1: Document Information
|*Class||To create a Product Item, set the value to “Product Item”||This option will only be available to a user who is part of the Product Manager User Group|
|*Product Item Number||A unique set of numbers that can be assigned to the Product Item|
|*Product Item Title||Product Item Name|
|*Site(s)||Site that the Product Item belongs to|
|Effective Date||This is system generated when the change request for the Product Item implementation has been released|
|Retire Date||This is system generated when the change request for the Product Item retirement has been released|
|Description||Optional field to describe the Product Item|
I. Click Create after filling out all necessary information in the metadata card.
II. The state of the Product Item becomes New Draft
To move your newly created Product Item forward, you now need to create a Change Request to control it. You can add the Product Item to a change request together with templates and documents. For instruction on how to do that refer to Work Instruction: Managing Change Request and follow Steps 1-7.
Alternatively create a Change Request to control the Product Item only. This is only relevant if you wish to introduce new Product Items.
Step 2.3 – Create Change Request to control Product Item Only – Change Manager
I. Select the Product Item you wish to move forward with. (only new Product Items)
II. Under Actions, click on “Create Change Request to Update”
III. Choose the right CR template, then fill in the metadata card accordingly.
a. For explanations on what each field is used for, please refer to Section 2.2 of Work Instruction: Managing Change Request.
Change Type will automatically be set to “New Change Request” as you are creating the CR to introduce a new Product Item.
The Change Scope will automatically include the Product Item that the Change Request was initiated from. This does not limit you from expanding the Change Scope and including other Product Items or other records.
For instruction on how to process a Change Request refer to Work Instruction: Managing Change Request and follow Steps 3-7.
As the Change Request progresses from Plan to Implementation and Closure, the Product Item will change state to “Ready for Approval”. You do not need to carry out any actions specifically with the Product Item, just continue with the Change Request.
When the Change Request is released, the Product Item will also become effective and the field for Effective Date will be automatically filled by the effective date of the Change Request.
Section 3: Updating a Product Item – Change Manager
After a Product Item has been created in the system you can no longer update metadata fields, even if you route it for an update. If you wish to refresh Product Item information, it is recommended to create a new Product Item and retire the old one.
A relelased Product Item can be included in a Change Request for updates or creation of (Product Item) documents. This is used to travel document updates together with the Product Item they are related to, so your Change Request information will show that by changing the documentation, your Product Item might also be affected. You can initiate an Update Request directly from the Product Item by clicking the “Create Change Request to Update” button under Actions.
After a released Product Item is tied to a New Change Request, it will change state to “Effective – Version Updating”, but the metadata will not become editable. Add related documents or templates you wish to create/ change together with the Product Item in the Change Scope Field.
The Product Items item will only be released once the CR is released and will inherit a new effective date from the Change Request.
Section 4: Retiring a Product Item – Change Manager
After a Product Item has been created in the system you can only retire the Product Item by clicking the “Create Change Request to Retire” button under Actions and going through the Change Request process for retirement. Alternatively, include the Product Item in another Reitre Request.
Refer to Work Instruction: Managing Change Requests Section 8.2 to understand this process.
Section 5: Creating Product Item Lot – Product Manager / All Contributors
Once the Product Item is created, a Product Item Lot can be created. The person to create a Product Item Lot should either be part of the All Contributors or Product Manager User Groups.
I. Select the Product Item that you would like to create the Product Item Lot number for
II. Under Actions, click on “Create New Product Item Lot
III. In the metadata, all values should automatically populate except for “Lot Number of Serial Number” and “Description”. Type in the Lot Number and if you wish, add a description.
IV. Click Create.
Note: There can be more than one Product Item Lot number associated to a single Product Item. The Product Item name will also be associated to the lot number.
Section 6: Making a Product Item Lot “Not Current” – Product Manager / All Contributors
When a Product Item Lot is no longer needed, it can be placed on “Not Current – Archive” state.
I. In the Browse window, on your Home Screen, open the “2. Main Views” view
II. Select “7. Products” and then the “4. Product Lots” view.
III. Choose the Product Lot that you wish to place on “Not Current – Archive”
IV. On the left side of the screen, under State Transition, click on “Not Current – Archive”
Making a Product Item Lot archived will not have any implications on the Product Item.