CAPA Management Process

CAPA Corrective and Preventive Action

corrections (which address immediate issues) It doesn’t eliminate the issue permanently, but it
allows a process or work to continue.

Corrective Action: Elimination of the cause or causes of an existing nonconformity or undesirable

situation in order to prevent recurrence.

Preventive Action: This prevents potential occurrences.

Corrective Action Sequence

1. Promptly identify and document the problem.

Use 5 Why questioning to acquire details and determine if this is an isolated event or if it is
significant and has the potential to recur. Reporters may indicate that the problem is pervasive, but
it may be limited. When documented, quality events should be reported to management.

1. Implement a correction or containment or temporary repair.

This may include removing a defective item from production

1. Find the cause of the issue.

Use 5 Whys to help pinpoint a problem statement. Use an Affinity or Ishikawa (fishbone) diagram to
help determine the root cause.

1. Determine the solution that will prevent a recurrence.

Solutions can include new parts, process changes, and even system changes.

1. Implement the corrective action and ensure that everything is documented.

2. Verify that the action continues to be effective and that the problem does not recur.

Document the evidence of continued success

Tools to support RCA – 5Whys & Fishbone

5 Whys - identify root causes by exhausting the question “why?”. Drill down further to sub-causes,
ask why they occurred too.

The logic is that you’ll make your way through all of the potential causes and end up identifying the
one that doesn’t have a proper answer to why?

Fishbone or Ishikawa – gives a more detailed look at multiple potential influencing factors against a
root cause, great for people diagnostics

Start by drawing a fish. Where the head would be, write out the problem or defect. Then, the bones
will be labeled using the major categories of potential causes.
Tools to support RCA – 8D

Criteria for a Good CAPA Plan

Specifically, the procedure should include clear guidelines for:

1. Identifying an issue

2. Evaluating the criticality of an issue

3. Investigating the root cause of an issue

4. Developing resolution plans

5. Implementing resolution plans

6. Measuring effectiveness of resolution plans

7. Updating and recording procedural changes

8. Communicating CAPA-related information

CAPA is typically reserved for systemic issues in which the same complaint is reported continuously.

This decision is best made by evaluating the severity, harm and complexity of the issue.

Quantity and severity are the two key factors to determine CAPA’s necessity.

). Ensure the method used to investigate and identify the root cause is documented in the CAPA
Plan.

Preventive Action: Identification and elimination of the cause(s) of potential nonconformities in

order to prevent occurrence

Corrective is reactive. Preventive is proactive

A non-conformity refers to a gap in a particular service, product, process or in the quality

management system itself, where specifications or requirements are not met

A potential non-conformity refers to an issue that has the potential to develop into a non-
conformity, such as a trend identified at management review or a quality issue that does not at the
point of review represent a failure to meet a specified requirement.

Roles & Responsabilities

Account Management - Provide monthly CAPA reporting to client

Country Leadership – Overall accountability for region’s compliance to CAPA Management process

Site Leadership (Site Director) - Functional area responsible for the Non-conformity / CAPA process.
Review and approve CAPAs raised by Operations Management or Other Departments at key stages:
Plan, Implementation, Effectiveness Verification. Review and follow-up on CAPA status in GMRs.
CAPA Owner for site level NCs/PNCs - Ownership of Initiation, Investigation, Implementation and
Effectiveness Verification.

Operations Management (Senior Operations Manager and/or Operations Manager) - CAPA Owner
for NCs or PNC at ADC operational level - Ownership of Initiation, Investigation, Implementation and
Effectiveness Verification • Initiation of CAPA process following Identification of non-conformity or
potential non-conformity. Review and follow-up on CAPA status in GMRs

All departments - Timely identification of non-conformities or potential nonconformities and

determination of the need for a CAPA by notifying the Site Leadership and/or Operations
Management.

Client Supplier Quality Assurance (SQA) - Review, approval and coordination of Supplier SCAR CAPA
plans.

Sitel CAPA Management Process Flow Chart

1. Identification - Identify non-conformity & Notify Site/Ops Management,

2. Evaluation - Evaluate non-conformity & Conduct impact assessment
3. Investigation - Conduct RCA & Determine root cause & Identify appropriate resolutions
4. Resolution Plans - Develop resolution plans & Establish effectiveness measurement &
Validate & approve resolution plans & SCAR Only - Review & Approve
5. Implementation - Implement resolution plans & Verify that actions were implemented &
Verify & approve action & SCAR Only - Review & Approve
6. Effectiveness Check - Verify Effectivness- Issue resolved – NO - Resolution Plans – YES -
Request approval for CAPA closure & Verify Effectiveness & Approve CAPA Closure & SCAR
Only - Review & Approve
7. Update Procedures - Recommend updates & Account Level Review (MR, SQMSR, SSO)

Inputs

Quality issues/gaps identified in:

 People  Performance  Material  Processes  Security  Quality Management System

Process Step

Identification

Evaluation Investigation Resolution Plans Implementation Effectiveness Check Update Procedure

Outputs

Evaluation

Impact/Risk Assessment  MR, SQMSR review – if potential global impact  Investigation Decision

Investigation
RCA – method and evidence  Root Cause/Probable Cause  Required Resolution

Resolution Plans

Correction  Corrective Actions  Preventive Actions  Effectiveness Measurements  Validation &

Approvals  Approved CAPA form

Implementation

Correction  Corrective Actions  Preventive Actions  Effectiveness Measurements  Validation &

Approvals  Approved CAPA form

Effectiveness Check

 Verified Effectiveness / Issue Resolution  Approved and closed CAPA form

Update Procedure

GMR, MR & SQMSR review  Updated Procedures (CAPA, Other)

The CAPA system at Sitel Group is a closed-loop process to ensure that corrective and/or preventive
actions for identified issues are taken without undue delay and assessed for effective
implementation. This process is used both to reactively address existing issues to assure they do not
reoccur and to proactively prevent foreseeable issues. The CAPA process involves:  Identification of
an issue – Non-conformity or potential non-conformity  Evaluation of the issue, its criticality, impact
and need for correction, corrective and/or preventive action. An impact level of High, Medium or
Low is assigned  Investigation of the issue to determine the root cause  Development of
Resolution Plans – planning and documenting appropriate corrections, corrective and preventive
actions which are proportionate to the non-conformities/potential non-conformities encountered as
well as determining measures to be used to verify effectiveness of actions.  Implementation of
planned Resolution Plans  Measuring Effectiveness of Resolution Plans - verifying that the actions
were actually effective.  Continuous Improvement of procedures