Overview


The CAPA module is used to address the root cause of issues that may be systemic, high risk or has a number of stakeholders involved. For minor issues it may be preferable to use the Issue Management Module (Deviations), NCM module or the Customer Complaint module depending on the context of the issue.


A high level overview of the CAPA process is below:




An out-of-the-box workflow of a CAPA consists of these steps:

  • Initiate        
  • Investigate        
  • Approval        
  • Implement
  • Verify
  • Closed

Explanation of CAPA Form Sections

  1. Basic Details Section


Fields

Field Explanation

Parent Process
  • Displays a link to the parent process (If the CAPA record was initiated from another module/process)

Number
  • Automatically generated with the following format : CAPA-XXXXX where XXXXX is the next sequential number

Source of CAPA
  • Allow selection from the following options Audit, Customer Complaint, Deviation, Management Review, Non conforming material, Other.

Responsible Department
  • Allow selection from all the departments in the system Administrator, customer service, human resource, IT, Manufacturing, Marketing, Quality, Sales

Category
  • Allow selection from the following options Calibration, Computer System, Customer Complaint: Product, Customer Complaint: Service, Equipment/Facility Issues, External Audit: ISO, External Audit: Other, External Audit: Safety, External Audit: ISO,Internal Audit: Other, Internal Audit: Safety, Internal Audit: ISO

Title
  • Allow free text entry

Problem Description
  • Allow free text entry

Attachment
  • Allow uploading of one or more files
  1. Immediate Actions Section

   


Fields

Field Explanation

Were any immediate actions taken ?
  • Allow user to select whether any immediate actions were taken or not.

Actions Taken
  • Displayed if Immediate actions were taken
  • Allows free text entry

Responsible Person
  • Allow selection from all available users in the system

Date and Time
  • Allow selection of Date and time

Attachment
  • Allow uploading of a single file
  1. Scope Section


Fields

Field Explanation

Scope
  • Allow selection of the section that is relevant to the scope of the CAPA. Options include Audit, Customer, Document, Equipment, Management Review, Process, Product, Supplier
  • Selection of these options will display the respective section on the CAPA record
  1. Impact Details Section



Fields

Field Explanation

Impact
  • Shall allow selection from: Major, Minor

Conduct Risk Assessment?
  • Displayed if Conduct Risk Assessment is set. When clicked opens the Conduct Risk Assessment dialog where the user shall be able to conduct a risk assessment. When the risk assessment is submitted then the link to the newly created assessment shall be added to the Link to Risk field, risk Rating to the Risk field, consequence to the Consequence field and indicator to the Indicator field.
  1. Required Approvals Section



Fields

Field Explanation

Investigation Team Required?
  • Allow user to specify whether an investigation team is required or not.

Investigation Lead
  • Allow selection from all users in the system. 
  • Visible if ‘Investigation Team Required?’ is set.
  • The Investigation step shall be assigned to this User

Investigation Team
  • Allow selection from all users in the system. 
  • Visible if ‘Investigation Team Required?’ is set.
  • These users are captured for recording purposes only and have no impact on the workflow

Verification/Effectiveness Check
  • Allow selection from all users in the system. 
  • Visible if ‘Investigation Team Required?’ is set.
  • The Verify step shall be assigned to this User
  1. Approvals Section (multiple Approvers can be specified)



Fields

Field Explanation

Approver
  • Allows selection from all users in the system. 

Department
  • Allow selection from all departments in the system. 

Approval Status
  • Field is only visible if it is the Approval step and is editable if the currently logged in user is the Approver.
  • Allows the Approver to make a selection from  'Approved', 'Rejected', 'NA'

Comments
  • Read-only field.
  • Displays the Comment the Approver enters in the Routing dialog when sending the CAPA to the next Approver.


  1. Audit Information (multiple Audits can be specified, displayed if 'Audit' is selected in Scope field)


Fields

Field Explanation

Audit Type
  • Allow selection from: Internal, External – Regulatory, External – Customer, External - Other

Audit Number
  • Allow free text entry

Audit Date
  • Allow selection from a date

Auditor
  • Allow selection from all users in the system

Additional Details
  • Allow free text entry

Attachment
  • Allow user to attach a file


  1. Customer Information (multiple Customers can be specified, displayed if 'Customer' is selected in Scope field)



Field

Field Explanation

Customer Lookup
  • When clicked, allow selection from the customer list in the system.
  • Only a single customer can be selected (if more customers are required then add another Customer section)
  • If a Customer is selected then the Name (Customer Name), Contact Name, Email and Phone shall be set automatically from the selected Customer.

Name
  • Free text field, allow inputting the customer's name.

Contact Name
  • Free text field, allow inputting the customer contact's name.

Email
  • Free text field, allow inputting the customer's email.

Phone
  • Free text field, allow inputting the customer's phone.

Other Details
  • Free text field, allow inputting other details with regards to the customer.



  1. Document Information (displayed if 'Document' is selected in Scope field)



Field

Field Explanation

Related Documents
  • Allow selection from all approved Documents in the system


  1. Equipment Information (multiple Equipment can be specified, displayed if 'Equipment' is selected in Scope field)




Field

Field Explanation

Equipment Lookup
  • When clicked, allow selection from all the equipment in the system.
  • Only a single equipment can be selected (if more equipments are required then add another Equipment section)
  • If a Equipment is selected then the Equipment Name, Number, Status and Location shall be set automatically from the selected Equipment.

Equipment Name
  • Allow free text entry.

Number
  • Allow free text entry.

Status
  • Allow selection from these following options Calibrated, Not Calibrated, Out of Service, Under Calibration.

Location
  • Allow free text entry.

Other Details
  • Allow free text entry.


  1. Management Review Information (displayed if 'Management Review' is selected in Scope field)



Field

Field Explanation

Review Date
  • Allow selection of a date from a calendar.

Review Background
  • Allow free text entry.

Additional Details
  • Allow free text entry.


  1. Process Information (multiple Processes can be specified, displayed if 'Process' is selected in Scope field)



Field

Field Explanation

Process Name
  • Allow free text entry.

Stage/Step
  • Allow free text entry.


  1. Product Information (multiple Products can be specified, displayed if 'Product' is selected in Scope field)



Field

Field Explanation

Product Lookup
  • When clicked, allow selection from all Products in the system. 
  • Only a single Product can be selected (if more Products are required then add another Product section)
  • If a Product is selected then the Number, Name, Version and Location shall be set automatically from the selected Product.

Name
  • Allow free text entry.

Version
  • Allow free text entry.

Location
  • Allow free text entry.

Batch Number
  • Allow free text entry.

Lot Number
  • Allow free text entry.

Manufacturing Date
  • Allow selection from a calendar.

Other Details
  • Allow free text entry.


  1. Supplier Information (multiple Suppliers can be specified, displayed if 'Supplier' is selected in Scope field)



Field

Field Explanation

Supplier Lookup
  • When clicked, allow selection from suppliers in the system.
  • Only a single Supplier can be selected (if more Suppliers are required then add another Supplier section)
  • When a Supplier is selected, the Business Name, Contact Name, Email and Phone shall be automatically set form the selected Supplier.

Business Name
  • Allow free text entry.

Contact Name
  • Allow free text entry.

Email
  • Allow free text entry.

Phone
  • Allow free text entry.

Other Details
  • Allow free text entry.


  1. Decision



Field 

Explanation

Approval Decision
  • Allow selection from ‘Proceed’, ‘Rejected’ and ‘Return for more changes/information’. This field is editable and visible to the last Approver assigned to the Approval step of the workflow. The last Approver makes the final decision after reviewing the Comments and Decisions of all previous approvers. 
    • If field is set to ‘Proceed’ then the CAPA shall be allowed to move to the ‘Implement’ phase (and all planned actions shall be started)
    • If field is set to ‘Return for more changes/information’ then the CAPA shall be allowed to move to the ‘Initiate’ phase.
    • If field is set to ‘Rejected’ then the CAPA shall have to be ‘Closed’

Additional Information
  • Allow free text entry. Field is editable and visible if the current user is the last Approver


  1. Cost


Field

Field Explanation

Item
  • A free text field allowing inputting the name of the item

Cost
  • Allow inputting the numerical value, which is the price of the corresponding item.


  1. Action Plan




Field

Field Explanation

Actions Required? 
  • If checked, PLAN ACTIONS and START ACTIONS buttons shall appear to allow planning of Actions.

Plan Actions
  • When clicked, the Action Plan dialog shall appear to allow the planning of actions.
  • For more information on Action Plans click here

Start All Actions
  • If clicked, then all planned actions shall be started and assigned to the responsible users
  • If not clicked, then the planned actions shall be auto started after the Approval step.


  1. Investigation Outcome


Field

Field Explanation

Is the issue already under investigation?
  • Allow selection from ‘Yes’ or ‘No’

Link to related CAPA record
  • Allow selection from all Pending CAPAs. 
  • Visible if ‘Is the issue already under investigation?’ is set to ‘Yes’.

Root Causes
  • Allow selection from: Materials, Facilities, Equipment / Instrument, Computer Systems, Personnel – Operator Error, Personnel – Lack of Training, Planning, Documents, Management, Inspector Error. Allow selection if ‘Is the issue already under investigation?’ is set to ‘No’.



Additional Details
  • Allow free text entry, visible if ‘Is the issue already under investigation?’ is set to ‘No’

Has this issue occurred before?
  • Allow selection from ‘Yes’ or ‘No’. Visible if ‘Is the issue already under investigation?’ is set to ‘No’

Related Issues
  • Visible if ‘Has this issue occurred before?’  is set to ‘Yes’. Allow selection from all Closed CAPAs in the system.

Attachments
  • Allow user to attach multiple files.


  1. Verification



Field

Field Explanation

Summary of Actions Performed
  • Allow free text entry

Evidence that Root Cause has been Addressed
  • Allow free text entry

Attachment
  • Allow user to attach a file.

CAPA completed as planned?
  • Allow selection from 'Yes' or 'No'

Further CAPA required?
  • Allow selection from 'Yes' or 'No'

New CAPA
  • Visible if 'Further CAPA required?' is set to 'Yes'
  • Allows you to create a new CAPA (which shall be linked with the current CAPA record)