Segment 1: CAPA General Information

What is CAPA?

  • CAPA stands for Corrective and Preventative Actions.
  • A concept within Good Manufacturing Practices (GMP).
  • Focuses on systematic investigation of discrepancies (failures/deviations) to prevent recurrence.
  • Part of the overall Quality Management System (QMS).

Corrective Actions vs. Preventive Actions

Corrective Action: Reacting to existing problems, complaints, or nonconformities and fixing them.

Process includes: Reviewing problem, finding cause, developing action plan, implementing, evaluating effectiveness.

Preventive Action: Detecting potential problems/nonconformities and eliminating them before they occur.

Process includes: Identifying potential problem, finding cause, developing preventive plan, implementing, reviewing effectiveness.

Objective of CAPA

Ensures corrective/preventive actions are effective and systematic investigation is pivotal. Must be integrated into QMS to:

  • Collect data on existing/potential problems
  • Investigate and analyze data to find root cause
  • Address issues and institute procedures to avoid recurrence
  • Document the entire process
  • Become part of company culture across all levels

Regulatory Requirements

  • Medical Devices (21 CFR 820.100): CAPA system required for US market.
  • Drug CGMPs (21 CFR 211.192): Investigations and deviation justifications required; inadequate investigations are common deficiency.
  • Preclinical GLPs (21 CFR 58): Corrective action required for testing facility management and study directors.
  • Clinical GCPs: Effective corrective action implied in sponsor/investigator responsibilities.
Why we need CAPA Process: Beyond regulatory requirement, it's good business practice that reduces liability, improves customer satisfaction, prevents financial losses, strengthens reputation, drives continual improvement, and achieves operational excellence.

Training Ground Rules & Participation

  • Put cell phones on vibrate.
  • Actively participate and ask questions freely.
  • Must attend entire session to receive credit.
  • Offer pertinent situations/examples from work area or past experience.
  • Unresolved issues go to "Parking Lot" for later follow-up.

Program Objectives

Participants will be able to:

  1. Explain CAPA General Information.
  2. Explain the CAPA process including:
    • Identification of the Problem
    • Evaluation, Investigation and Analysis
    • Development of an Action Plan
    • Implementation and Follow-up

Program Details

  • Intended Audience: All employees
  • Recommended Size: 15-20 participants
  • Frequency: New employees & employees with CAPA responsibilities
  • Presentation Time: 2.0 hours
  • Preparation Time: 1 hour

Who Participates in CAPA?

  • Quality Assurance & Quality Control
  • Manufacturing
  • Packaging
  • IT
  • Facilities
  • External Consultants

Major Components of CAPA System

  1. Identification: Problem, nonconformity, incident or potential issue.
  2. Evaluation: Magnitude and potential impact on company.
  3. Investigation Procedure: Develop with assigned responsibilities.
  4. Analysis: Thorough analysis with proper documentation.
  5. Action Plan: List all tasks to correct/prevent problem.
  6. Implementation: Execute the plan.
  7. Follow-up: Verify completion, assess appropriateness and effectiveness.

Segment 2: Identification of the Problem

Reporting the Source

Record specific origin of information that initiated the action. Documentation helps investigation, implementation, evaluating quality system, and communicating completion.

Possible Sources: Customer complaints, internal audits, risk assessments, trending data, etc.

Explaining the Problem

Write complete, concise description with sufficient information for clear understanding.

Questions to answer: What happened? Product impact? Data available? Isolated or systemic?

Determining Evidence

List specific information demonstrating problem exists. Examples: High service requests/returns for product defect; increasing downtime for equipment problem.

Other evidence: Scale tickets, cleaning logs, process-controller data.

Segment 3: Evaluation, Investigation & Analysis

Evaluation

Determine need for action, level of action, and potential impact (costs, product quality, etc.).

Assessment of Risk: Evaluate seriousness of problem to drive subsequent actions.

Remedial Actions: Activities to correct problem and minimize further risk; must be documented thoroughly.

Investigation

Develop Investigation Process/Plan with objectives, procedures, responsibilities, resources, documentation. Ensures completeness.

Program Implementation & Lesson Plan

Materials Needed

  • PowerPoint slide deck
  • Knowledge Assessment & Answer Key
  • Training Sign-in Sheet
  • Projector, computer, screen
  • Pens/pencils, flip chart/markers

Assessment Requirements

Knowledge Assessment with 80% passing grade. Facilitator grades; remediation and re-test if needed.

Lesson Plan Flow

  1. Introduction and ground rules
  2. CAPA General Information (Definitions, differences, objectives, regulations)
  3. Importance and participants
  4. Major components of CAPA system
  5. Identification of the Problem (Source, explanation, evidence)
  6. Evaluation, Investigation & Analysis
  7. Wrap-up and assessment