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corrections (which address immediate issues) It doesn’t eliminate the issue permanently, but it
allows a process or work to continue.
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.
Use 5 Whys to help pinpoint a problem statement. Use an Affinity or Ishikawa (fishbone) diagram to
help determine the root cause.
Solutions can include new parts, process changes, and even system changes.
2. Verify that the action continues to be effective and that the problem does not recur.
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
1. Identifying an issue
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.
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.
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
Client Supplier Quality Assurance (SQA) - Review, approval and coordination of Supplier SCAR CAPA
plans.
Inputs
Process Step
Identification
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
Implementation
Effectiveness Check
Update Procedure
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