Introduction 

Errors are usually a part of any process, action, or activity. There is always a percentage of error that happens. The practice must be to refine it and bring the errors down as low as humanly possible.  

To adhere with industry regulations and to remain compliant with various policies, quality processes of organizations have multiple checks and internal policies in place to address the non-compliances and errors that occur during the lifecycle of manufacturing a product. The focus of these processes is to address the errors, analyze them, fix them and ensure that they do not occur again.  

Often during this process, the regulatory burden makes it difficult for quality process individuals to provide their complete focus to solving the errors in a way that they are traceable backward, permanently fixed, and provide insights about any matters that need to be addressed immediately. 

One of the most talked-about and feared issues in a quality process is the CAPA. Corrective Action and Preventive action is in fact an opportunity for improvements in the quality processes.  

Pain points of CAPA Process 

In MDIC Case for a quality program, organizations highlighted the mindset that has been built over the years due to the regulatory burden.   

“Our staff dreads being assigned a CAPA.  It is burdensome and is seen as a punishment instead of an improvement opportunity”  

“Our CAPA system is bloated and is focused on creating documents instead of resolving issues”  

 *Source – MDIC cfq whitepaper. 

MDIC Case for Quality initiative conducted in-depth research and released the top 3 pain points that were put forth by people handling quality processes.  

1.     Lack of clarity on whether an issue should be treated as a CAPA or not – The research found that more than 70% of the CAPAs reviewed could be managed through existing quality systems and did not require to go through the CAPA process.  

2.     Overlap and duplication issues leading to redundant work – Not knowing if a similar issue has occurred before either as a non-conformance, complaint or even a CAPA is a void that needs to be addressed. Having the visibility of an issue’s prior occurrence/nonoccurrence could speed up the resolution process in some cases. 

3.     Resource ownership of the CAPA – Advanced planning of who should own a CAPA and take it through to completion. Lack of traceability of updates to the ownership of CAPA.    

Process Improvements 

1. Traceability of your CAPAs 

Trace your CAPAs from their source to the resolution. Tracking every minute detail ensures that you can catch patterns and gaps proactively rather than after the damage is done. Paper-based processes might make it difficult to have this view but digital QMS allows you to link your CAPAs to the related items in the process. This ensures that whenever you look at a CAPA, you can instantly find answers to questions like 

o   “Which non-conformance is related to this CAPA?” 

o   “Did this CAPA trigger any change requests?” 

o   “Is this CAPA related to any other quality issue that our organization might have seen in the past?” 

o   “Does this CAPA impact any documentation?” 

o   “Who is handling this CAPA?” 

o   “Who all signed off on this CAPA?” 

2. Risk Management through CAPA 

ISO 13485 and 14971 provide guidelines for the quality processes centered around risk management of the processes. Organizations have risk management plans which are designed after careful consideration of numerous factors such as potential hazards and their probability of occurrence, the magnitude of the harm that could be caused by the hazards, or if the risk level reaches an unacceptable level.  

Integrating the corresponding risk parameters which are/could be impacted by a CAPA would enable a dynamic, up-to-date risk management plan that provides a strong base for the entire manufacturing process and would play a vital role in ensuring consistent high quality of the products.  

3. Cross-functional collaboration 

 CAPA is not always department-specific. Sometimes an issue impacts different departments. An issue might occur in a department, but its impact could be multi department. Resolution of such issues requires strong cross-functional collaboration and inter-department communication. There should be policies that guide teams to collaborate and work on CAPAs. 

 Transparency and details which help the management understand ‘who the owner of the actions is’ is taken to resolve the CAPA. Which teams have collaborated on this to make it happen can help provide visibility of the issue lifecycle and highlight any potential gaps and improvement points.  

 Conclusion 

 These CAPA process improvements have been implemented in iQuality’s IQMS. Our regression testing and SMEs have observed a considerable decrease in the pain points due to the process improvements being included in the initial design of the CAPA process.