This article details the process of establishing and overseeing a Corrective and Preventive Action (CAPA) using the CAPA Module within the 1factory system.
Step 1: Creating the CAPA
Two approaches can be utilized to generate a CAPA within 1factory. The first involves its direct creation from a Non-conformance Report (NCR), while the second entails starting from scratch using the CAPA Module. Both methods will be discussed in detail below.
From an NCR:
After creating an NCR and outlining the issue, you can conveniently initiate the creation of a new CAPA by clicking the "NEW CAPA" icon on the left side bar of your screen. This action ensures that the details from the NCR are effortlessly carried over to the newly generated CAPA.
From Scratch:
To generate a CAPA within the 1factory system independent of its origin from an NCR, you can initiate the process by creating a CAPA from scratch. Simply go to the CAPA tile located under the "NCRs CAPAs" Tab.
Once you have clicked on the CAPA tile, you can now create a CAPA from scratch by clicking on the "NEW CAPA" Icon located at the top left corner on the CAPA summary list.
After clicking on the icon, a slide out will appear. Enter the details of the Part Number against which you would like to initiate the CAPA. Once you have done this, click "GO" and a new CAPA will be generated.
Step 2: Assign team members to the CAPA (D1)
Upon initiating the CAPA, you can now commence building your CAPA team. To achieve this, click on the "Manage" tab within the CAPA. This will open a slide-out where you can:
- Assign the CAPA Owner
- Assign CAPA Team Members
- Set the CAPA due date
Step 3: Complete the remaining CAPA activities' (D2-D8)
After establishing the CAPA team, you can now progress through the remaining stages of the CAPA process, including:
- D2: Define and describe the problem - Specify the problem by quantifying the who, what, where, when, why, how, and how many (5W2H) aspects of the problem.
- D3: Develop interim containment plan; implement and verify interim actions - Formulate and implement containment actions to isolate the problem from affecting the customer.
- D4: Determine, identify, and verify root causes and escape points - Identify all potential causes explaining why the problem occurred. Also, identify reasons why the problem went unnoticed initially. All causes must be verified or proven, avoiding reliance on vague brainstorming. Techniques like 5 Whys and cause-and-effect diagrams can be employed to map causes against the identified problem.
- D5: Choose and verify permanent corrections (PCs) for problem/nonconformity - Through preproduction programs, quantitatively confirm that the selected correction will effectively resolve the problem for the customer.
- D6: Implement and validate corrective actions - Define and implement the most effective corrective actions (CA).
- D7: Take preventive measures - Modify management systems, operational practices, and procedures to prevent the recurrence of this and all similar problems.
- D8: Congratulate your team - Acknowledge the collective efforts of the team. The organization should formally express gratitude to the team for their contributions.
CAPA Stage Owners
To facilitate a prompt completion of the CAPA, 1factory enables the identification of a stage owner for each discipline of the 8D. To assign an owner to a stage, click on the desired stage, and a slide-out will appear, allowing you to assign an owner and set a due date for that particular stage of the CAPA.
After assigning the owner and due date, click on the "Save" icon to finalize this action. Upon saving the owner and due date, a task will be automatically generated for the assigned owner, and an email notification will be sent.
After assigning an owner to a stage, the owner can access their assigned stage through two paths.
From the CAPA List:
In the CAPA list, use the heading filter for Tasks and opt for "ASSIGNED." This will present a list of CAPAs where you have been designated as the owner of a stage which is still OPEN.
From the Tasks List:
By clicking on the "MY OPEN" tasks, the user will access a list of tasks, including those where they are assigned as the owner of a CAPA Stage.
To complete a stage of the CAPA, the owner will choose the respective stage of the CAPA, prompting a slide-out. Within this interface, the owner can furnish more detailed information regarding the completion of the stage and switch the status from "OPEN" to "CLOSED." Additionally, the owner has the option to enhance the stage by attaching an image using the Paper Clip icon.
It is essential to highlight that only the designated owner of the stage possesses the authority to close it.
Note: In accounts featuring E-signature functionality, the owner must input their password before selecting the save button.
Step 4: Closing the CAPA
After completing all assigned tasks linked to the CAPA, the CAPA Owner can proceed to review the entire CAPA. Through the Manage tab, they have the authority to change the CAPA Status from "OPEN" to "CLOSED."