Purpose
Learn how to:
- Create and update the following Recorded Issues: Complaints, Nonconformances, Supplier Issues and Continuous Improvements
- Create CAPA and CAPA Attachments with the Recorded Issues
Outcomes and Prerequisites
Expected Outcome
- Users are equipped to handle all Recorded Issues (except for Audit Findings) and CAPAs in SimplerQMS
Prerequisites for all
- Must be logged in to SimplerQMS
- Access to the site that the Recorded Issue is assigned to
- 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 the Quality Assurance Responsible
- Must be a member of one of these ‘User Groups’
- Quality Assurance Responsible
Prerequisites for creating Recorded Issues
- Must be a member of one of these ‘User Groups’ to create new records:
- Complaint Handler, Audit Handler and/or NC Handler
Prerequisites for creating CAPAs
- Must be a member of the ‘User Group’ to create new CAPAs:
- CAPA Handler (named Issue Handler on the Recorded Issue metadata card)
Section 1: Workflow overview
The flowchart below outlines the Recorded Issue (RI), CAPA and CAPA Attachment flows, which are all divided into phases. The blue lines indicate the most common routes and the red markings split the flows into sections according to the sections in this work instruction: RI without CAPA (2 and 4), RI and CAPA (2, 3, 4 and 6) or RI, CAPA and CAPA Attachments (2, 3, 5, 4 and 6).
Section 2: Create Recorded Issue
Step 2.1 – Create Recorded Issue – NC/Complaint Handler
When you create a recorded issue, as per the flowchart above, the Issue Handler will determine if a CAPA is needed. If this is not the case, you should jump to section 4 after completing section 2. If it is needed, you will need continue with section 3 after section 2, and then jump to section 4 to complete the RI (unless CAPA Attachments are needed).
Option 1: Create a Recorded Issue by itself
I. In the Create New section, on your Home Tab, click on Document
i. Click on the Create (+) next to the Home Tab and choose Document from the dropdown list
ii. On the left side of the screen, expand Create and click on Document
II. To create a Recorded Issue from this selection, you need to define the Class as Recorded Issue Document
III. Select the right template.
A Metadata card will pop up. (Less data will be prefilled than with Option 2.)
Option 2: Create a Recorded Issue based on an existing record
If you want to create a Customer Complaint (as illustrated below) or Supplier Issue, go to the Customer or Supplier view and use the actions menu per below. The metadata card will then be prefilled with the relevant data.
I. Under Go To, click on Customers
II. Select the customer you received a Complaint from, and in the Actions menu, click on Create Complaint
III. Select the relevant Complaint template and click Next
A Metadata card will pop up.
Step 2.2 – Fill metadata card
Part 1: Document Information
| Field name | Description | Note |
| Short Title* | The title of the complaint | |
| Recorded Issue Type* | Select the Recorded Issue Type | |
| Complaint Receiving Date* | The date when the complaint was received. Based on your procedures, this date may define the due date you need to enter in section 2 on the metadata card. | |
| Sites* | One or more sites should be selected | |
| Document Type* | Select the relevant Document Type, often determined by the Recorded Issue Type | |
| Department* | The relevant department | |
| Process* | The relevant process | |
| Archive | If needed, select one or more archives |
Section 2: Workflow Process Information
| Field name | Description | Note |
| Responsible Person* | Select the responsible person | |
| Authors* | Select the author | |
| Reviewers | If needed, select the reviewers | |
| Quality Assurance Responsible* | Assign relevant QA responsible. This will automatically assign the QA Responsible to the following roles on the CAPA (if created): Responsible Person, Initial Approvers and Approvers. | User needs to be member of the Quality Assurance Responsible user group to be selected |
| Issue Handler* | Select person who is the issue handler | Member of the CAPA Handler user group |
| Due date* | Select the date the RI needs to be completed (i.e. based on Complaint Receiving Date) | |
| Approvers* | Select the approver | |
| Effective Date* | If you know the effective date at this stage, select the effective date | |
| Latest Review Close Date | Automatically filled with the latest date the review is closed. | Read-only |
Section 3: Relations
| Field name | Description | Note |
| Related CAPA | Will automatically be filled when a CAPA is created and related to the complaint | |
| Result of Audit: | If needed, link to a relevant audit | |
| Relations | Select the relevant Relations (i.e., objects like products, customers, suppliers etc) | |
| Customer* | Select the relevant customer. May be pre-filled, i.e., if a Complaint is created based on a customer selection | Depending on Relations |
| Product Item* | Select one or more products that are related to the Recorded Issue | Depending on Relations |
| Product Lot List | If needed, select one or more product lots | Depending on Relations |
| Product Item Lot Number | Insert a Lot Number if needed | Depending on Relations |
| Standard Chapter | If needed, link the issue to a chapter in ISO13485:2016 | |
| Doc Ref Working Copy | If needed, link the issue to another document |
If a Complaint or Nonconformance is created, please fill section 4 related to MDR.
Section 4: Medical Device Reporting – At Record Creation
| Field name | Description | Note |
| Product/incident resulted in injury/death | If you know the answer to this question, then fill in Yes or No | |
| Risk the product/incident may result in injury/death | If you know the answer to this question, then fill in Yes or No |
I. When you have filled in the information, click Create.
II. Your Recorded Issue form will now open in Word.
Step 2.3 – Draft the Recorded Issue and notify the Issue Handler- Author
I. At this stage, the Recorded Issue document is open in word and the assigned author/RI handler can start drafting.
II. Check in the RI once the drafting has been completed. Under State Transition, click on Draft Completed – Notify Issue Handler
III. The state of the Recorded Issue should be Issue Handler Assessment.
At this stage, the Recorded Issue is now assigned to the Issue Handler. This person needs to assess if a CAPA is needed to process the issue.
I. If CAPA is not needed – select the RI and click Assessed – No CAPA Needed.
II. Sign your electronic signature and proceed to Section 4.
If a CAPA is needed, go to the next Error! Reference source not found.. (You can also refer to work instructions Managing Audits from step 5.2)
Step 2.4 – Closure of Recorded Issue with open CAPA- QA Responsible
If a CAPA is created, the recorded issue goes into a CAPA Processing state and waits for the CAPA to be processed and closed before the Recorded Issue can be closed.
The Recorded Issue can be moved forward immediately without waiting for the CAPA processing, if needed.
This is NOT a recommended option, however if the standard that you comply would allow this, make sure it describes in your company procedure, and only the QA Responsible user role can see and press the button ‘Allow Closure of Recorded Issue without CAPA Closure’ when the Recorded Issue is selected.
I. Select the recorded issue, under state transition, click on Allow Closure of Recorded Issue without CAPA Closure
II. Enter the electronic signature to complete the closure
III. The recorded issue will then be assigned to the recorded issue author to proceed with the next step
a. Although the CAPA is still open and on Draft when the recorded issue has been closed, the recorded issue state will become CAPA Process Closed – Ready for Issue Review and Approval.
IV. The recorded issue author can now send the document either for review, approval or back to draft
NOTE: The related CAPA to this recorded issue will be able to move forward and can continue the steps as it is to complete the CAPA without affecting the state of the recorded issue.
Section 3: Creating CAPA
Step 3.1 – Create CAPA – CAPA Handler
To create a CAPA for the RI, select the RI and click Create CAPA in the Actions menu.
Search for or select the relevant template for the CAPA and click Next.
Step 3.2 – Fill out metadata card for CAPA
Part 1: Document Information
| Field name | Description | Note |
| Short Title* | The title of the CAPA | |
| Sites* | One or more sites should be selected | |
| Document Type* | The relevant Document Type (i.e. CAPA) | |
| Department* | The relevant department | |
| Process* | The relevant process | |
| Archive | If needed, select one or more archives | |
| CAPA Severity | If needed, select the severity of the CAPA | |
| CAPA Status | Indication of the CAPA status (state in workflow) | Read-only |
| Category | If needed, assign a category | |
| CAPA Effectiveness Assessment | Will show “CAPA not assessed” until assessment is done | Read-only |
Section 2: CAPA Conclusions
| Field name | Description | Note |
| Initial Conclusion | Initial conclusion of the CAPA plan | Mandatory to provide prior to Initial Approval |
| Conclusion of Closure | Conclusion of Closure of the CAPA should be filled before the final approval, hence this should not be done, but in Step 3.4 – Review & Approval of the CAPA | Mandatory to provide prior to the final approval |
Section 3: Workflow Process Information
| Field name | Description | Note |
| Responsible Person* | Pre-filled, but can be edited | Pre-filled with the QA Responsible from the RI, |
| Authors* | Select the author | |
| Initial Reviewers | If needed, select who should review initial plan | |
| Initial Approvers* | Approvers of the initial CAPA plan is pre-fille but can be edited. | Pre-filled with the QA Responsible from the RI, |
| Reviewers | If needed, select the reviewers | |
| Approvers* | Approvers of the final CAPA is pre-filled but can be edited. | Pre-filled with the QA Responsible from the RI, |
| Due date* | Select the due date for the CAPA | |
| Effective Date | If you know the effective date at this stage, select the effective date | |
| Latest Review Close Date | Automatically filled with the latest date the review is closed. | Read-only |
Section 4: Relations
| Field name | Description | Note |
| Related Recorded Issue | Will automatically be filled when a CAPA is created and related to the Recorded Issue | Pre-filled |
| Relations | Select the relevant Relations (i.e., objects like products, customers, suppliers etc) | |
| Customer* | Select the relevant customer. May be pre-filled, i.e., if a Complaint is created based on a customer | Depending on Relations |
| Product Item* | Select one or more products that are related to the Recorded Issue | Depending on Relations |
| Product Item Lot Number | Insert a Lot Number if needed | Depending on Relations |
| Standard Chapter | If needed, link the issue to a chapter in ISO13485:2016 | Pre-filled |
| Initiated from Template | If needed, link the issue to another document | Pre-filled |
| CAPA Attachments |
When you have filled in the information, click Create.
Your CAPA form will now open in Word.
Step 3.3 – Drafting of CAPA and sending for initial review and approval- Author
I. The CAPA Author can now start drafting the CAPA.
If there is a need to split the CAPA up into several parts (referred to as “CAPA attachments” in SimplerQMS, see Section 1: Workflow overview and for step by step instructions, go to Error! Reference source not found. Error! Reference source not found.), these attachments can be created, drafted and reviewed/approved when this main CAPA’s initial review and/or approval has been done by the end of this Step 3.2.
When the drafting is done and document checked-in again follow the next steps to route for initial review and/or approval or start creating the CAPA Attachments.
II. Select the CAPA either in the Detail Listings view after the Complaint is selected or find the CAPA by going to the CAPA view in the “Go To” pane.
III. The Effective date and Initial Conclusion must be entered before the document is routed for approval.
IV. Then click Route for Initial Review or Route for Initial Approval without Review.
a. If the CAPA is no longer needed, then click Not Current – Archive.
V. If CAPA has been routed for initial review, it will now be awaiting all the initial reviewers. Each reviewer must click “My Initial Review Task Completed” to move it forward for Initial Approval.
a. Alternatively, the CAPA Handler (or Process Manager) can click “Close Initial Review Immediately” and sign with electronic signature to move it directly for Initial Approval.
VI. Fill the Initial Conclusion field on the metadata card and save it before clicking Route for Initial Approval.
VII. Click Approve Initial CAPA and sign it, to send it for further processing (next state being Ready for Execution per flowchart in Section 1) or Reject Initial CAPA to send it back to draft. All changes made in the review process will be kept if it is rejected.
The CAPA will then transit into a state, Ready for Execution, and CAPA Attachments should be created and processed before moving on with the main CAPA, if needed. Please go to Section 5, if needed, otherwise continue with Step 3.3.
Step 3.4 – Review & Approval of the CAPA
The CAPA can now be reviewed and approved. The review is optional and when the final approval is done, the CAPA will be released and go into a pending effectiveness state and await the effectiveness assessment (WI – Assessing Effectiveness of CAPA) . In addition, the Recorded Issue can be closed after its own Review and Approval in the next step.
Now, fill Conclusion of Closure on the metadata card, with a conclusion of the CAPA. This is a requirement before the CAPA can be approved and released.
Then finalise the Review and Approval by doing the following:
I. Select the CAPA
II. Click Route for Review or Route for Approval without Review
III. Click My Review Task Completed, if reviewed
IV. Click Approve CAPA and Sign it or reject it
Approving and signing does the following:
I. The CAPA is released and moved into the state ‘Pending Effectiveness Assessment’
II. A periodic task ‘Assessment # for CAPA xx’ will be created for the Effectiveness Assessment and assigned to the Responsible Person from the CAPA. See the task in the Details Listings view.
III. The related Recorded Issue can now be closed by reviewing and approving it. You can find it in the Recorded Issue in the Detail Listings view or navigate to the relevant Recorded Issue view from the Go To menu.
Step 3.5 – Rejecting the CAPA (if needed) – Approver
I. The CAPA is sent back to Draft, which means the full review and approval process needs to be done. All changes to the document made in the past will be kept.
Section 4: Review & Approve Recorded Issue
This section has now been reached, either due to:
A) CAPA processing is done and the CAPA is now pending an effectiveness assessment or
B) The Issue Handler has assessed that no CAPA is needed
If a Complaint or Nonconformance is created, please continue with the next step to finalise the MDR reporting, jump to Step 4.2 – Send Recorded Issue for review and approval.
Step 4.1 – Complete MDR Reporting- Responsible Person
Select the Recorded Issue document to complete the MDR reporting.
Please fill the MDR reporting properties under the MDR re-evaluation section on the metadata card.
I. Ensure to fill the MDR Reporting Date and MDR Reference if there is an injury or death involved or a risk for an injury or death, and press “MDR Reporting Completed.”
II. If there is no injury or death and no risk for injury or death, press “MDR Reporting Not required.”
Following this step, the Recorded Issue is ready for review and/or approval.
The state of the Recorded Issue should be CAPA Process Closed – Ready for Issue Review and Approval.
Step 4.2 – Send Recorded Issue for review and approval-Author
You (i.e., the complaint handler) should now process the Recorded Issue by routing it for approval with or without review (Refer to WI: Managing Quality Documents)
Remember that the Effective Date must be set before the document is routed for approval.
When the approval process is completed, the Recorded Issue working copy will end in the state Recorded Issue Completed and Closed. It will then be released and in a PDF version and reach its Effective state.
The CAPA has moved into the CAPA Pending Effectiveness state. To assess the CAPA effectiveness, refer to the work instruction- Assessing Effectiveness of CAPA.
If an update is necessary for the Recorded Issue, select it and under the State Transition, click on Route for Updates.
Step 4.3 – Route Recorded Issues for Updates- Author/Responsible Person
When an update is necessary, the audit finding author or responsible person can accomplish the update.
I. Select the recorded issue, in the state transition click on Route for Updates
II. The recorded issue generates a version 2 of the document, and automatically assigns the document to the author. The state should be Awaits Updates.
When the audit finding has been updated, it assigns to the author and will be ready for editing.
III. Author receives a notification about the recorded issue and document can be found in the author’s Assigned to Me box, drafts the document in the working copy, saves the document and check in, you can also refer to the assignment description as a guide
IV. Once the drafting is completed, the author can send the document for review or approval
Make sure that the effective date is added before sending for approval.
V. Once all the approvals have been captured, state is Recorded Issue Completed.
Section 5: Create CAPA Attachments
A CAPA Attachment is often used for splitting the CAPA process up into several parts. It is generally easiest to work with all the related CAPA documents via the Detail Listings view, when selecting the main CAPA.
A CAPA Attachment is part of the Quality Document class, with its own Document Type. In the relations section of the metadata card, the field Parent Document, shows the name of the main CAPA the attachment is linked to. Vice versa, the field CAPA Attachments on the main CAPA indicates the CAPA Attachments it is linked to.
When the CAPA Attachment has been reviewed and/or approved, the main CAPA can be moved forward for approval per Section 1: Workflow overview
Step 5.1 – Create a CAPA Attachment – CAPA Author
I. To create a CAPA Attachment, click Create CAPA Attachment while having selected the relevant CAPA and ensure it is in the state Ready for Execution, which it is automatically transferred to after the Initial Approval.
a. If CAPA Attachments are created, they must be fully approved (or archived) before the main CAPA can be sent for Review and Approval.
Search for the relevant template or select the class Quality Document and select a template to base the CAPA Attachment on and click Next.
Step 5.2 – Create a CAPA Attachment – CAPA Author
Section 1: Document Information
| Field name | Description | Note |
| Short Title* | A suggested CAPA Attachment name will appear, but is editable | Pre-filled |
| Sites* | One or more sites should be selected | |
| Document Type* | The selected document type is predefined by the template used but can be edited. | Depending on Relations |
| Department* | The relevant department | Depending on Relations |
| Process* | The relevant process | Depending on Relations |
| Archive | If needed, select one or more archives | Pre-filled |
Section 2: Change Control
| Field name | Description | Note |
| Requires Change Request | The document type determines if a change request is required, hence this property can only be changed by changing the doc. type. | |
| Requires Periodic Review | The document type determines if a periodic review is required, hence this property can only be changed by changing the doc. type. |
Section 3: Workflow Process Information
| Field name | Description | Note |
| Responsible Person* | Add or edit the Responsible Person | Pre-filled with the QA Responsible from the RI, |
| Authors* | Select the author | |
| Reviewers | If needed, select the reviewers | |
| Approvers* | Add or edit the Approvers | Pre-filled with the QA Responsible from the RI, |
| Due date | Select the due date for the CAPA Attachment | |
| Effective Date | If you know the effective date at this stage, select the effective date |
| Field name | Description | Note |
| Relations | Select the relevant Relations (i.e., objects like products, customers, suppliers etc) | |
| Standard Chapter | If needed, link the issue to a chapter in ISO13485:2016 | Pre-filled |
| Parent Document | This is the main CAPA that the current CAPA Attachment is linked to. | Pre-filled |
| Initiated from Template | If needed, link the issue to another document | Pre-filled |
| CAPA Attachments | Not used |
II. When you have filled in the information, click Create.
III. Your CAPA Attachment form will now open in Word.
When the drafting is done and the document checked-in again, notice that the CAPA Attachment is a “child” to the main CAPA and grandchild to the Recorded Issue.
Navigate to the new CAPA Attachment by clicking CAPAs in the Go To menu and navigate to the relevant CAPA,
I. Select it, choose the CAPA Attachment in Detail Listings
II. Click Proceed to confirm the right Document Type has been entered. The Document Type, CAPA Attachment, was pre-selected when the CAPA Attachment was created, hence no action is needed to change the Document Type.
III. Route the CAPA Attachment through the Review, the reviewer checks out the document and provide comments if any. Save and close the document, back in SimplerQMS, in the state transition, click on My Review Task Completed
IV. When the review is completed, the author makes the final changes to the document, sets the effective date and route for approval
V. The approver approves the document by signing the electronic signature
When final signature is done, the CAPA Attachment will go into a Released state and allow the main CAPA for final Review and Approval per Section 1: Workflow overview. Hence please continue by going back to Step 3.4 – Review & Approval of the CAPA or create additional CAPA Attachments by repeating this step.
Section 6: CAPA Effectiveness Assessment
Please see work instruction WI – Assessing Effectiveness of CAPA for step-by-step instruction on how to manage the Effectiveness Assessment in SimplerQMS.