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  • GP-023 Change control management
  • R-023-001_002 Change control

R-023-001_002 Change control

Description​

  • Change name: Change in documenting Nonconformity (NC) and Corrective Actions Preventive Actions (CAPA)
  • Change description: currently the same template is used for documenting Nonconformity and CAPA and this sometimes makes it difficult to understand which nonconformities are closed, which nonconformities led to a CAPA. Therefore, it's advisible to split the template and, as a result, have one template for nonconformity records and one template for CAPA records.
  • Source of change: Nonconformity coming from ISO 13485:2016 BSI audit (second stage). Nonconformity reference: R006001-66, CAPA reference: R006001-67

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities)
    • No (it does not require notification to Regulatory Authorities): it is a change to improve an internal process (NC and CAPA process)
  • Risk analysys impact: the proposed change does not modify any existing risks and does not introduce new risks in the nonconformities and CAPA process.
  • Quality documentation impact: GP-006, T-006-001, T-006-002, R-019-001_001

Approval​

The change is approved.

Plan​

  • Creation of a new template for documenting CAPA (T-006-003) - Quality department
  • Modify template for documenting nonconformity (T-006-001) to remove the fields related to CAPA - Quality department
  • Update the nonconformity workflow in Jira - Quality department
  • Update the CAPA workflow in Jira - Quality department
  • Update T-006-002 in Jira - Quality department
  • Update GP-006 - Nonconformities, CAPA to update the NC and CAPA workflow and include the new template for CAPA - Quality department
  • Validation of new/modified templates (R-019-001_001) - Quality department

Implementation​

Implementation date: 2023-03-04

Record signature meaning​

  • Author: JD-004 Giulia Foglia
  • Review: JD-005 Alfonso Medela
  • Approval: JD-001 & JD-003 Andy Aguilar
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  • Description
  • Impact analysis
  • Approval
  • Plan
  • Implementation
  • Record signature meaning
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