Six steps procedure for corrective and preventive action

The investigation team picks the possible causes of the problem marked on the Fishbone diagram. You should then spread down each of the potential causes by asking the question “WHY” up to five successive occasions or up to the point the participants feel the best possible root cause is already attained.

The team also brainstorms all the possible causes of the problem. You should ask “Why does this happen?” As each idea is answered, a branch is drawn on the fishbone. Document every step of the investigation and findings.

You can write the causes in several places if they relate to several categories listed above. Again asks “Why does this happen?” for each category. Write sub-causes by branching off the bones.

Continues to ask “Why?” and generate deeper levels of understanding of causes. This will help you to identify and then address root causes to prevent future problems.

If found beneficial include a Pareto analysis can be done separately to show the fewest (20%) most significant causes which have been causing the highest (80%) level of effects.  

Step 4: Prepare action plan

When you will reach to the potential solutions group them in order of difficulty to implement. Not every solution would have equal impact on eradicating the root cause. Some are easy to implement and potential improvement is significant. Some are harder to implement and possible return on investment would be less significant.

You and the investigation team should come with a list of action plans (corrective and preventive actions) and justify which would have the most practical impact on removing the defects.

Step 5: Implement action plan

Once the corrective and preventive action plans are prepared, you should implement the action plans. For instance, you can undertake a list of process improvement works targeting the elimination of causes that have resulted in the defect.

Some preventive actions which are beneficial over the long term can also be implemented at the same time to prevent potential similar type of other defects.

Step 6: Follow up action plan

The final stage of corrective and preventive action process is to periodically follow up the effectiveness of the actions implemented earlier. You should prepare a schedule to revisit the corrective and preventions and check if the plans were not deviated from the target. Also you should measure if the root causes have been eliminated completely from the process.

Areas where corrective and preventive actions can be taken

The CAPA system shall be comprehensive. You should include analysis of the following areas as applicable to the product or GMP site:

– Manufacturing processes

– Work operations and scrap rates

– Quality audits

– Quality records (e.g., nonconforming product records, stability studies, analytical laboratory investigations, inspection and test records)

– Complaints

– Returned products

– Deviations or concessions

– Adverse events/medical device reports

– Management reviews

– Field alerts or advisory notices; and

– Supplier data

Other aspects to consider during CAPA exercise

Where necessary you should include statistical methodology to detect recurring quality issues.

The corrective and preventive action should be verified or validated in accordance to pre-established and approved specifications to ensure that such action is effective and does not adversely affect the quality of finished product.

The significance of the product and any hazard associated with the defective product shall be taken into consideration when determining the corrective and preventive action to be taken. A risk analysis shall be performed to determine significance of the defective device and hazard, if necessary. You should document the risk analysis methodology and mitigation actions.

You should prepare failure analysis to the level necessary to determine the root cause of the nonconformity (e.g., a defective component or raw material). Keep all the record of the investigation, follow-up and conclusion.

CAPA Information shall be submitted for periodic Management Review. CAPA activities shall be documented and supporting documentation maintained in accordance to site record retention practices.

If changes are required to make as part of corrective and preventive action process, those changes shall be assessed for further process impacts. Changes shall address and are not limited to, the following:

– Methods and procedures,
– Design,
– Personnel training, and
– Specifications

Information related to quality issues or nonconforming product shall be communicated to the following as applicable to the issue and/or product:

– Personnel directly responsible for assuring the quality of the applicable product or the prevention of such problems;

– Management; and

– Regulatory Authorities and/or Notified Bodies.

The impact of a nonconformity on other production units, lots or similar products shall be assessed. A documented investigation shall include evaluation of and not limited to, the following:

– Manufacturing processes;

– Quality processes;

– Failed components;

– Design related issues; and

– Process anomalies.

Design Deficiencies detected as a result of a nonconformity investigation shall be corrected in accordance with the documented design control and change control standards and procedures.

Corrective and preventive action documentation

CAPA Documentation shall include:

– Description of the nonconformity, including identification of the Batch or lot affected;

– Scope of the nonconformity including any other product, batches, or lots potentially impacted by the nonconformity;

– Risk or hazard assessment associated with the nonconformity;

– Root cause investigation;

– Corrective actions taken (short-term and long-term);

– Preventive actions taken (short-term and long-term);

– Conclusion, including Disposition of the impacted batch (es) or lot(s);

– Verification or validation to demonstrate effectiveness;

– Follow-up activities

– Identification of person(s) conducting the investigation;

– Date of investigation;

– Signature of site quality team approving the CAPA report and date of Approval.

Summary

Corrective and preventive action process is an important technique to identify defects and implement actions to eradicate the causes of the defects. CAPA analysis is synonymous to continuous quality improvement. The method is not hard to follow and widely used during quality investigations. However, sometime inexperienced team can quickly jump into conclusion which produces no real improvement and defects keep coming back.