GMP Training Primer: CAPA
This is the first in series of articles focusing on training in specific subjects related to good manufacturing processes and quality systems.
Many manufacturers run afoul of the FDA over their corrective and preventive actions (CAPA) procedures. And since CAPA can impact almost every area of your manufacturing operations, it’s crucial for all employees to understand at least the basics – the what, why and how. But boiling the complexities of CAPA down to an introductory level can be a real challenge.
The following outline shows how noted GMP training expert Dave Gallup of GMPtraining.com approaches the task.
Give an overview of what the training will cover. For example, definitions, investigation, problem analysis and CAPA Action Plans.
Part One: General Information
In addition to defining the term, talk about CAPA objectives, the importance of the CAPA process, federal CAPA regulations, personnel responsibilities and components of a CAPA system. In this section, it’s important to discuss the difference between corrective actions and preventive actions.
Part Two: Identifying the Problem
This section would include reporting a problem, explaining it and collecting evidence. Trainees should discuss potential sources of identifying problems, such as risk assessment or data trending.
Part Three: Evaluation, Investigation and Analysis
Attendees should learn how to determine the need for action, the level of action needed and its potential impact. Key aspects in this stage are risk assessment, and identifying and documenting remedial actions.
The investigation section should cover developing an investigation plan that includes objectives, procedures, responsibilities, resources and documentation. Under analysis, discuss how to brainstorm potential causes and be sure to stress the difference between observed symptoms of the problem and the root cause.
Part Four: Developing an Action Plan
In this section, trainees should learn how to compile and implement an Action Plan that includes everything needed to address the problem, including methods, responsibilities, tasks and documentation. The Action Plan also should cover how to deal with changes it will cause and how to train employees to handle those changes.
Part Five: Implementing the Action Plan
This section should explain how to complete the tasks and objectives in the Action Plan and how to evaluate results once the plan is complete.
Throughout the training, be sure to give trainees opportunities to contribute to the discussion and share their ideas and experiences.
At the end of the training, you should review key points, take questions and administer the knowledge assessment or test.
In next week’s issue, we’ll cover training on data integrity.
The complete CAPA Overview training package, including slides, leader’s script and knowledge assessment, is available as part of the FDAnews Customizable Training Series for drug manufacturers and devicemakers.