Corrective and Preventive Action (CAPA)

Medical device sponsors should pay a lot of attention to CAPA, its initiation, implementation, effectiveness, closure and documentation. It is one of the best tool to improve the quality system. But, CAPA can consume a lot of human and financial resources if it is probably done right.

Sponsor should have a system, procedure, work instruction and forms and to assign responsibilities for the initiating, requesting, implementing and verifying the effectiveness of CAPA. The CAPA procedure applies to prevent and correct nonconformities related to materials, components, subassemblies, finished products, manufacturing processes and the whole quality system.

Some of the associated documents with CAPA procedure are as follows:

·        Corrective and Preventive Action Request Log

·        Corrective and Preventive Action Request Form

·        Work Instruction for Corrective and Preventive Action Request

·        Corrective and Preventive Action Records.

·        But, in this day and age, all of this CAPA can be managed using a computer system like Trackwise.

·        The above request log and form can be deployed a small or startup medical device.

Corrective Actions are implemented to address actual nonconformities occurred in the organization. Anyone can initiate a CAPA, but it is advisable that QA should authorize CAPA request and review all CAPA for completeness and effectiveness before closure.

CAPA request includes a description of the unsatisfactory condition to be corrected and explain how quality is impacted. CAPA request may be directed to the company's internal departments as well as to its suppliers and subcontractors as well.

Examples of cases which may initiate corrective actions are shown as follows:

·        Identification of a nonconforming product;

·        Identified problem with a manufacturing process or work operation;

·        A nonconformity identified during a regulatory or third-party audit;

·        Field performance problem reported by servicing;

·        Customer or regulatory complaint like patient’s injury;

·        Nonconforming delivery from a subcontractor;

·        Findings from internal audit or customers;

·        Identification of any other component, device, process or condition that does not conform to specifications, documented quality system, or requirements of the ISO 13485 standard or 21 CFR 820.

Preventive actions, however are initiated when quality performance data indicates that there are trends of decreasing quality capability or effectiveness of the quality system. For example: increasing incidence of product nonconformities traceable to the same common cause; excessive equipment problems; or increasing number of internal audit findings against the same element of the quality system or department.

When a problem requiring preventive action is identified, the process of dealing with the problem follows the same steps that apply to corrective actions as described above.

Upon receiving a request for corrective action or preventive action, the responsible manager investigates the cause of the problem that initiated the request, proposes a corrective action or preventive action to be taken, and indicates the date by which the corrective action or preventive action will be fully implemented. A great and well thought CAPA plan should be warranted.

Another key concept for CAPA is the effectiveness of the corrective action and preventive action taken to remediate the nonconformity. QA should follow up with an inquiry or an audit to determine if the corrective action or preventive action has been implemented effectively. When there is objective evidence that the corrective action is effective, the CAPA can be closed out. Examples of methods to gauge the effectiveness is the measurement of any recurrences of the nonconformity or also perform trending for a certain period after the corrective action and preventive action had been implemented. If more work is needed to fully implement the action, a new follow-up date is set.

If any CAPA is not seriously implemented and the root causes are not resolved. Similar or even identical nonconformity can occur. It is the best interest in the long run to have a robust quality system. The cost of noncompliance is can be costly in the long run.

Sponsor should also have a spreadsheet to track all the CAPA outstanding and ensure all CAPAs are reasonably closed within a time-frame. I once have a client who get a 483 observation for not closing CAPA in 4 years.

Reference	Criteria
ISO 13485  8.5.2	Does the company take action to eliminate the cause of nonconformities in order to prevent recurrence? Are corrective actions appropriate to the effects of the nonconformities encountered?
ISO 13485  8.5.2.a	Has a documented procedure been established to define requirements for reviewing nonconformities including customer complaints?
ISO 13485  8.5.2.b	Has a documented procedure been established to define requirements for determining the causes of nonconformities?
ISO 13485  8.5.2.c	Has a documented procedure been established to define requirements for evaluating the need for action to ensure that nonconformities do not recur?
ISO 13485  8.5.2.d	Has a documented procedure been established to define requirements for determining and implementing action needed, including, if appropriate, updating documents?
ISO 13485  8.5.2.e	Has a documented procedure been established to define requirements for records of the results of action taken?
ISO 13485  8.5.2.f	Has a documented procedure been established to define requirements for reviewing corrective action taken and its effectiveness
ISO 13485  8.5.3	Has the company determined action to eliminate the causes of potential nonconformities in order to prevent their occurrence? Are preventive actions appropriate to the effects of the potential problems? Has a documented procedure been established to define requirements for evaluating the need for action to prevent occurrence of nonconformities? Has a documented procedure been established to define requirements for determining and implementing action needed? Has a documented procedure been established to define requirements for records of the results of action taken? Has a documented procedure been established to define requirements for reviewing preventive action taken?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.