CAPA

What is CAPA?

 

It is the abbreviation for Corrective Action and Preventive Action. These aspects of CAPA have been connected traditionally, but are ideally distantly related. These actions are processes for identifying, documenting, and addressing defects, deficiencies, and nonconformities. The main difference between two is that:

Corrective Action: Elimination of the cause of an undesirable situation or an existing nonconformity in order to prevent reoccurrence. It is based on non-conformance event that has happened in the past.

 

Preventive Action: Identification and elimination of the cause of the potential for a nonconformity to occur. It is based on preventing a non-conformance to occur in the future. 

There is a misassumption that the two-process work together in series, in standards such as ISO 900 and FDA 21 CFR 820 it is shown that description of preventive action follows directly after the description of corrective action. But they are separate, preventive action ideally proceeds with corrective action to avoid the need for corrective action.

CAPA processes are used in medical device development, manufacturing, pharmaceuticals and food processing, current Good Manufacturing Process (cGMP) and also used in quality management process, also used in variety aspects of product development like design, production, product testing, product packaging, distribution, shipping and post marketing use. The aspects of preventive and corrective action are taken back to PDCA (component of preventive action that encourages documentation). 

 

21   CFR 820 

It stands for title:

➢ 21 Code of Federal Regulations 820. 

➢ Title 20 governs the food and drug for the FDA. 

➢ CFR 820 it is the quality system regulation thar applies to manufacturers of medical devices.

21 CFR heavily borrows from the ISO 9000: It requires provision to create and maintain procedures for implementing corrective action and preventive action so that problems with the devices can be addressed by the employees.

Three things to be followed in CAPA:

1.     Gathering and analysing information to find existing and potential problems and nonconformities.

2.     Observing quality issues and proper corrective and preventive actions are applied.

3.     Ensuring the effectiveness of corrective and preventive actions. 

Types of steps involved in Corrective action:

 

➢ Promptly identify and document the problem: 5 Why questioning is used to obtain details, that if it is a isolated event or significant which has the ability to reoccur. The 5 Why template is used in identifying the root cause of the problem. 

 

➢ Implement a correction: This may include removing a defective item from production.

➢ Find the cause of the issue: Ishikawa diagram is used to determine the root cause of the problem.

•        Determining the solution that will prevent a reoccurrence: Solutions can include like change in process, new parts and changes in the system. 

•        Implementing the corrective action and ensure that everything is documented.

•        Verify that action needs to be continues to be effective and problem does not occur: Evidence should be documented.  

Risk Based Prioritization

A predefined risk-based prioritization along with the corrective action procedure will help in removal of non-conformities. They are prioritized based on frequency (frequently, occasionally, rarely) and impact (negligible, critical and even injury or death).

Non-Conformance: According to ISO 9000:2000 on conformity is considered as nonfulfilment of a requirement. It describes the failure to stick to the procedure, standard or requirement.  

Non-Conformity: Non-conformance and non-conformity are same, but the word nonconformance is no longer used.  

             

Non-Compliance: It describes the failure to attach to a law or regulation.

Preventive Action

It not only identifies the potential problems but also removes them for improvement. Changes that are made through preventive process, controls should be included to prevent from nonconformities. Preventive Action now it a part of Good Planning and Risk Management. One of the procedures required by the ISO 9001. Companies kept past records of the nonconformities and preventive action taken place. But some practitioners considered it was unclear concerning for the problems. Considering preventive action was risk practitioners directed to ISO 9004. “Managing for the standard success of an Organisation – A quality management approach”.

ISO 9000:2015- Eliminates the need for both the predefined procedures for preventive action and corrective action. As of this ISO 9000:2015 you can document what the problem was and how you fixed it. 

CAPA Related Actions

Immediate Action: It does not eliminate the issue permanently but eliminates the problem immediately.

Corrective Action: Eliminates the cause of non-conformity and prevents repetition.

Preventive Action: Prevents reoccurrence of the non-conformity. 

Tools Used to Analyse Potential Problems

➢ Hazard and Operability Study (HAZOP): It is a methodical study or a sequence process which is in development or in operation. Identifies the problems that risks to equipment.

➢ Failure Modes & Effects Analysis (FMEA): It is a procedure for identifying failure during a design or service and during a manufacturing process of a product.

➢ Fault Tree Analysis (FTA): It is used in safety and relatively engineering, where a system is broken into subsystems to see where problems has occurred. It is used in pharmaceutical development and manufacturing. 

Connection of CAPA on QMS Processes

 

➢ Complaint Handling 

➢ Customer Feedback 

➢ Nonconforming Product 

➢ Production and Process Controls 

➢ Supplier Management 

➢ Audits 

➢ Design Controls 

➢ Management Review 

Misconceptions about CAPA

➢ Extra workload.

➢ Training is too expensive.

➢ It is a punishment because something has gone wrong.

CAPA Report 

It is a consistent vehicle for recording problems and issues and their method of correction. Details include where the problem has occurred, the customer’s name and address, details of the problem whether there was an injury or product breakdown. It also states immediate action or correction action, and also record results.

Examples of CAPA 

 

1.     If a bucket is placed under a leaking garbage disposal then it is a correction.

2.     But if you inspect the whole drain and sink and realise that the unit repeatedly leaks and blocks because of a damaged seals and joints, and then removing it and replacing it with the effective garbage disposal which does not leak or clog is called as corrective action.

 

3.     If you check the U traps of the garburator in other sinks for existing problems and asking for the replacement of any new parts before they get failed then it’s a preventive action.

 SAI VEENA JANUMPALLY

saiveenajanumpally@gmail.com