OOS/CAPA – control your Out Of Specifications and optimize your corrective actions

OOS are at the center of important Business stakes: Do we need to reprocess batches, throw them away, downgrade them? Whatever the nature of corrective actions and/or preventive actions that are implemented, OOS are potentially revealing lack of process control. This is why, beyond Business stakes, there are important Regulatory stakes. All the more so since these OOS’s and their associated CAPA’s, are largely used as starting point during inspection. How to identify them, process them, record actions taken, verify action efficiency, implement then follow-up indicators… are issues addressed in this training course.

 Know OOS and CAPA Management Process.

 Know how to recognize and process OOS.

 Know how to differentiate Correction, Corrective Action, and Preventive Action.

 Know interactions between Validation, OOS, and IPC. Know risks and stakes regarding to managing or not OOS and CAPA.

 Know key points of an organization which allows ensuring regulatory Agencies and client satisfaction while staying pragmatic.

1. Regulation
Reminder about regulation regarding OOS and CAPA.

2. OOS: What is it?
Definitions. Terminologies concerning OOS.

3. CAPA: What is it?
Definitions. Terminologies concerning CAPA.

4. Relationship between OOS / CAPA / Validation / IPC
Relationship OOS / CAPA. In Process Control (IPC). Relationship Validation / IPC / OOS.

5. OOS / CAPA Management Process
OOS / CAPA Management Process. Importance of investigations. Quality Indicators and Executives Reporting.

6. Impact Analysis / Cause Analysis
Impact Analysis Process. Cause Analysis Process.

7. OOS/CAPA … Finanzielle Realität und Unternehmensinteressen
Client satisfaction and company success. The Risks to control.

8. . Cultural revolutions regarding Quality… Pains, but benefices
The cost of non-conformity. Change Control versus Change Management.

9. The ultimate goal… Client satisfaction
CAPA at the centre of the problem … … Risk Analysis at the centre of the solution.

PRACTICAL CASE STUDY
Practical Case Studies on actual OOS / CAPA.

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.