Title: CAPA as a Quality Sub-System
Course: PW-Course-Import-Test > Section: Module 6: Non Conformance and CAPA

Module 6

Now that you have initiated a non conformance and put the non conforming parts in quarantine, we are ready to take the next steps necessary to resolve the non conformance. Corrective and Preventive Action (CAPA) is a very essential quality tool used in the medical device industry. A Quality System of a company is incomplete without a CAPA subsystem.

In most companies a quality inspector does not work on the CAPA directly. The CAPA is most likely the responsibility of engineers, supervisors and managers. However the quality inspector plays a very integral role in assisting the investigation and other actions required by the CAPA.

Having a CAPA subsystem is a regulatory requirement and companies are required to have procedures and processes to fulfill those requirements.

Regulatory Requirements

First let us discuss the regulatory requirements that drives the CAPA quality sub-system. All medical device companies that manufacture and distribute products in the U.S. are governed by the Food and Drug Administration’s (FDA) code of federal regulations. For medical devices, this regulation is 21 CFR 820.  Section 820.100 lists the requirements of CAPA.

If a medical company decides to manufacture in the U.S. but ship products for use on patients outside the U.S., then this company needs to a follow regulations governing the particular country. Most countries, other than the US, uses ISO 13485 to regulate medical devices.

On the next page are the CAPA regulations as defined in ISO 13485 and FDA 21 CFR 820.  A medical device company will refer to these definitions and requirements when establishing their procedures. Do you know what regulations your company follows?

ISO 13485 - 8.5.2 Corrective Action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities.

ISO 13485 - 8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

FDA QSR 21 CFR 820 - Comment #159

“…the degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered.

CAPA Definitions

Now that we know what the regulations state, let us define the terms related to CAPA. You will come across these terms while working on a CAPA with an engineer or a supervisor assigned with a CAPA. Some of these terms are similar sounding but they have very different meanings and intents.

Non conformance: Non-fulfillment of a specified requirement

Correction: Action to eliminate a detected or existing non conformance. A correction can be made in conjunction with a corrective action. Corrections can be rework, repair, reinspect, fix documentation error, etc.

Corrective Action: Action to eliminate the cause of a detected non conformance or other undesirable situation. There can be more than one cause for each non conformance. A correction is not the same thing as a corrective action.

Preventative Action: Action to eliminate the cause of a potential non conformance or other undesirable situation.

A corrective action is taken to prevent recurrence while a preventative action is taken to prevent occurrence.

We will have a fun activity on the various types of actions later on in this module.