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Managing Product Items with Change Request

Purpose

Learn how to:

  • Manage Product Item implementation in SimplerQMS with Change Request

Expected Outcome

  • 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 Product Type

  • Must be a member of one of these ‘User Groups’
    • Metadata Administrator

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 5 implications:

  1. After a Product Item is created, it will not get released until you have completed the Change Request process.
  2. When Product Items are added to a Change Request for updates, their metadata fields become locked and cannot be directly edited. This emphasizes the controlled nature of updates through Change Requests and discourages unauthorized modifications.
  3. If you wish to make significant changes to a Product Item, it is recommended that you retire the old one and replace them by a new one. This approach is particularly relevant for extensive modifications, as it simplifies the update process and provides a clear version history.
  4. Product Update Action: This dedicated action strengthens control and approval processes for product updates like typo corrections or updates to the product type or description. It requires linking the specific product to the Change Request, providing pre-populated information for the assignee based on the existing product details. When assigned, it allows for modifications to the existing product values through the Action metadata card.
  5. 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
Field nameDescriptionNote
*ClassTo 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 NumberA unique set of numbers that can be assigned to the Product Item 
*Product Item TitleProduct Item Name 
*Site(s)Site that the Product Item belongs to 
Product TypeClassify items by their stage or purpose in the manufacturing process for streamlined inventory management
Effective DateThis is system generated when the change request for the Product Item implementation has been releasedUsers with the “Metadata Admin” user group can create new product types by clicking “Create + Product Type”
Retire DateThis is system generated when the change request for the Product Item retirement has been released
DescriptionOptional 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

Step 3.1 – Create Change Request to update Product Item Only – Change Manager

After a Product Item has been created in the system you can no longer update metadata fields directly on the item itself, even if you route it for an update. If you wish to refresh Product Item information create a Product Update Action related to the Change Request.

If the Product Item should be related to the Change Request as a reference since its related documentation is being modified, you can do so through the Relations field. Only include product items as Controlled CR Items if there are modifications to the Product Item itself that would require a new effective date or a Product Update Action.

A released Product Item can be included in a Change Request for updates or creation of (Product Item) documents. 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.

Step 3.2 – Create Product Update Action

Product updates are managed through Change Requests to ensure controlled modifications and minimize the risk of unauthorized changes. Product Update Actions can be used to modify Product Item metadata as part of an approved Change Request, but only for minor adjustments like correcting typos or updating descriptions or product types. If the product’s title or number is significantly altered, be sure to evaluate all related documentation thoroughly to prevent inconsistencies or compliance risks.

Note: Updating existing product items through Product Update Actions is not recommended to manage version control, as it may introduce significant compliance risks, including loss of auditability, data inconsistencies, and regulatory breaches. To ensure clear traceability and compliance, always create new product items for each version change, rather than modifying existing ones.

To create a Product Update Action in SimplerQMS:

I. Locate the relevant Change Request

II. Under the “Actions” section, click “Create Product Update Action”

III. Fill in the metadata card

Part 1: Action Information
Field nameDescriptionNote
* Short TitleProduct Update Action Name
Action DescriptionA brief explanation of the intended product updates included in the action. This should be informed by the Change Request and outlined for the assignee. 
ResolutionOptional field used to document the resolution or outcome of the action, especially if it’s related to a problem or issue.This field can be filled in by the assignee before the action is completed.
Responsible PersonThe individual ultimately accountable for the action’s completion and its associated product updates.This field will be automatically populated based on the initiator.
Assignee(s)One or more individuals tasked with carrying out the specific updates outlined in the action.
* Mandatory for AllIndicates whether all assignees must complete their assigned tasks before the action can be considered complete.If ‘Yes’ is selected, all persons listed in the Assigned to property need to complete the assignment.
* Site(s)The specific site(s) where the product update will be applied.This field will be automatically populated
Action TypeIdentifies the type of action being performed.
Standard Action: Choose this action to generate an assignment for users unrelated to specific objects.
Product Update: Choose this option if you wish to make updates to a Product Item.
When you click “Create Product Update Action”, the “Product Update” option will be automatically selected.

Part 2:  Relations
Field nameDescriptionNote
*Change RequestThe Change Request associated with this Product Update Action.Upon creating the Product Update Action under the “Actions” section, the system automatically associates it with the Change Request.
*Product Item to UpdateThe specific product item that will be modified through this action. This list is filtered to display only the relevant products item(s) related to the change request.

Part 3:  Action Dates
Field nameDescriptionNote
*Due DateThe target date by which the product update action should be completed.
*Grace PeriodTime allotted for finishing the action before the due date.
*Grace Period UnitThe unit of time used for the Grace Period

Click Create.

Note: The responsible person can edit all metadata except for the “Product Fields to Update” group.

Step 3.3 – Complete the Product Update Action

Completing the product update action involves a few key steps.

I. The assignee verifies the Change Request details to ensure they align with the intended product updates.

II. Access “Product Fields to Update” group and make any necessary adjustments based on the Change Request information.

a. The “Product Fields to Update” group will load the values from the Product Item, which can be edited by the Assignee:

  1. Updated Short Title
  2. Updated Product Number
  3. Updated Product Type
  4. Updated Description

III. Once all updates are finalized, the assignee marks the action as complete under State Transition.

Note: If you would like to revert to the original data from the Product Item while making adjustments to the values as an assignee, simply empty the value and the original value will be shown.

The Change Request can then be routed for review or approval. The Product Item(s) will only be released once the CR is released and will inherit a new effective date from the Change Request.

For instruction on how to process a Change Request refer to Work Instruction: Managing Change Request and follow Steps 3-7.

      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 Retire 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.

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