To establish a system that defines the criteria and methodology for taking corrective and preventative action on identified problems or negative trends identified through the analysis of incident reports, complaints, or findings that have been documented. Specific actions are not covered as part of this procedure because of the uniqueness of each incident or reporting. It does cover the procedure actions that are to be taken to address the incident, complaint, or negative trend. The correct CA/PA and timeline for each problem or issue will be based upon its characteristics and severity.

---

This procedure applies to internal and external concerns relating to quality, confidentiality, integrity, availability, reliability, safety, performance, or any product or service offered by centrexIT.

---

Senior IT Manager, vITMs, All process owners, and all centrexIT employees who have identified a problem or may be a stakeholder to a problem’s resolution.

---

Effective closure of a Problem ticket by identifying underlying root causes and performing corrective and preventative actions to ensure an effective resolution and prevent a re-occurrence of the problem.

---

An attached CAPA summary and details notes in the closed ticket. See attached document for summary file template. Please ensure to attach a final pdf version of the CAPA summary and include any notes or information given to clients.

• All notes from the CAPA meeting should be attached to the ticket. Any reports or summary that is reviewed or presented should also be included in the problem (PRB) work record.

---

1. Prerequisites:

• a. An identified problem. This can be a result of any of the following, but this is not a exhaustive or exclusive list.

• Complaints

• Incidents

• Non-conformances

• Audit Findings

• Management Review

• b. A PRB work ticket in Halo created following KB00032405

• c. An identified problem that does not have a simple solution following one of the other PRB ticket paths identified in KB00032405.

2. Initiating a CAPA

• a. To initiate a CAPA you must determine the following:

• What system or process has the problem?

• Who is the owner of that system or process?

• Who is involved with that process or product? (who are the stakeholders?)

• b. Assign the process or system owner as the “Assigned user” in Halo on the PRB work ticket.

• c. Add the additional following Relationships as “User – Assisting:”

• Client vITM – if applicable

• Client vCIO – if applicable

• Senior vITM and Quality Manager

• Security Manager

• Senior Director of Strategy

• Other applicable stakeholders

• d. define the initial steps this may include gathering needed data.

• Prior to the Initial meeting, gather as much data as needed. Request any needed data from any other departments, process owners, etc. Be prepared to present all relevant data in the initial CAPA meeting.

• e. Warm Handoff to Identified owner.

• Prior to the CAPA meeting, have a conversation with the identified process or system owner about the problem, explaining all pertinent information.

• Get their approval, if they disagree as being the owner, work with them to determine the appropriate owner. If an owner cannot be determined, work with Quality Manager to locate the appropriate owner.

• The person working the problem ticket to this point owns the Problem until the appropriate process owner agrees to be the owner. This owner than becomes the CAPA leader and will schedule the CAPA meetings.

• f. Schedule the Initial CAPA meeting.

• The owner of the PRB ticket and CAPA will schedule the first meeting. Attempt to find a time that as many people from the above list can attend. Keep the first meeting to 30 minutes.

3. Initial CAPA meeting

• In the first CAPA meeting, Owner and Problem initiator will present the defined problem and the data that has been gathered.

• The owner will then work with the CAPA team members to identify the following:

• Other team members or persons that need to be involved.

• Initial containment actions.

• Initial corrective actions.

• Initial preventative measures

• Owners or assignees for each of the above actions and measures.

• How effectiveness will be determined for each.

• By When Timeline for each of these actions and measures.

• Document these in the CAPA meeting notes to be attached to the PRB.

• Schedule a follow up based on the above actions and timelines. If not enough time was given to cover all this, work to close any gaps with the team or schedule an immediate follow up meeting to finish.

4. Subsequent CAPA meetings

• Continue working through the 8-D process for each action and measure and continue meeting as needed until all resolutions and effectiveness criteria have been met.

• D1 – Description of Problem

• D2 – Team Members, or person

• D3 – Containment Actions

• D4 – Root Cause Analysis and Root Cause Identification

• D5 – Corrective Action(s)

• D6 – Verification of Effectiveness

• D7 – Preventive Measures

• D8 – Closure

5. Closure

• Once the CAPA team determines the effectiveness of the actions and measures taken and effectiveness verification has been met the CAPA can be closed.

• To close a CAPA a final meeting should take place where all actions and effectiveness criteria can be reviewed.

• The CAPA summary should be completed and the final version attached to the PRB ticket before closure.

• The quality manager and Senior Director of Strategy must be present and approve of effectiveness and CAPA closure and CAPA summary.

• All notes from the meetings and all related documentation should be attached to the PRB ticket.

• If the review of the corrective/preventative action indicates that the CAPA was ineffective, the process must repeat until all criteria are met.

6. Presentation of findings

• Once a CAPA has been closed, the finding and results of the CAPA should be presented to any remaining stakeholders, such as the client or centrexIT teams as needed.

• If a client needs to be notified, a presentation or CAPA response summary should be created and presented with the approval of Senior Director of Strategy and Quality Manager.

7. Close the PRB ticket.

• Once all steps are complete, all documentation has been attached to the PRB ticket, and any applicable presentations or documents have been completed, the PRB ticket can be closed.

---

1. Definitions: a. Corrective Action: An action taken to eliminate the causes of existing nonconformity’s (problems, concerns, issues, incidents) or any other undesirable situation to prevent recurrence. b. Preventative Action: An action taken to eliminate the cause(s) of potential nonconformity’s (problems, concerns, issues, incidents). Sources of information for preventative actions may include work operations, audit results, records and documentation, management review, or customer complaint. c. Remedial Action: An action taken to alleviate the symptoms of existing nonconformities or any other undesirable situation. d. Root Cause: A fundamental deficiency that results in a nonconformance and must be corrected to prevent recurrence of the same or similar nonconformance. e. Disciplines of Problem Solving: The 8-step problem-solving discipline used in the identification, investigation, and resolution of CAPA.

2. KB00032405