New CAPA LOG &

CAPA Concepts
MAO
11/23/10

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 CAPA Process Concepts –
CAPA Log & Closure Rates
 Same CAPA Log for all Customer Complaints,
Internal and Supplier Nonconformances
 Use Column for CAPA Type to differentiate and sort for
reporting
 Different CAPA Log for Audit Observations
 Reason: Audit Data different from Nonconformance Data
 CAPA Investigation Closure
 30 days to complete investigation
 Applies to Customer Complaints, Internal Nonconformances and
Audit Observations
 45 days to complete investigation for Supplier
Nonconformances
 Based on external investigation, and potentially sub-tier supplier
issues
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 CAPA Process Concepts –
CAPA Leader
 CAPA Leaders
 Drive investigation for root cause analysis
 Recommend & Facilitate Closure of Corrective Action Plan
 Recommend & Facilitate Closure of Preventive Action Plan
 Preventive Actions will also roll into the Continuous Improvement Team for
approval and support.
 Action Plan Approvals
 All Action Plans will be approved by Quality Assurance and Manufacturing with
other required management approvers dependent on the Plan.
 Required: Director of Manufacturing
 Required: Quality Assurance
 Regulatory Impact - Director of Quality Assurance

 Customer Complaints & Nonconformances - QA Manager

 Others Requirement for approvals:

 New Part Design – R&D

 Validation Required – Director Quality Engineering

 Significant Financial Investment - CFO

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 CAPA Process Concepts -
Administration
 QA CAPA Administrator
 Manage oversight of the process and tracking ‘Action
Plans’ and ‘Effectiveness’ to completion
 Implementation Due Date = Last Action Plan (task) Due
Date
 CAPA Status – includes Open, Closed, Implementation,
Effectiveness, and Invalid
 Action Plan and Effectiveness Check (Pre-determined &
approved) will become part of Standard Form
 QA CAPA Coordinator
 Facilitate completion of CAPA Log
 Based on Job Jackets, OPS Log, Customer Questionnaire
 Facilitate review of documentation and samples
 QA Checklist will be provided to document tasks completed
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CAPA Process Concepts - Supplier
 Supplier Quality Management
 Determine Defect Classification for CAPA
Response Required
 Track and Trend minor issues
 Future:
 Drive Process Controls at Supplier
 Perform Process Review via Checklist with Top Suppliers
 Drive Certification Efforts with Top Suppliers via Six
Sigma Process

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 CAPA Concepts - Metrics
 Monthly Reporting
 By Customer Complaints, Internal
Nonconformances, Supplier Nonconformances
 Track and Trend Data
 Report Major Concerns
 Open Actions
 Closure Timeliness
 Facilitate Management Reviews
 Facilitate Continuous Improvement
 Supplier Meetings & Reports
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