5 MOST COMMON Reasons Behind CAPA Management Problems (And, How to Deal with them)

Maintaining discipline of processes, workflows, quality management, and continuous improvement is difficult without Corrective and Preventive Actions (CAPA) process especially if you are associated with a highly regulated industry like Life Science. The technology intervention has positively impacted the effectiveness of CAPA with the introduction of CAPA Management software systems.

For every organization having a quality management system software, the Corrective and Preventive Actions (CAPA) process is an inevitable part to ensure all the quality issues are inspected, analyzed, and corrected thoroughly.

What is CAPA?

Before heading to the discussion of 5 MOST COMMON Problems with CAPA Management, it would be sensible to understand the concept of CAPA. It will help you have a better understanding of every step.

CAPA refers to the improvements that any organization makes to manage non-conformities and eliminate its root-cause to prevent their reoccurrence. It is basically a defined set of actions by the regulatory authority that the organizations take to eliminate the quality issues and their reoccurrences – be it for manufacturing, procedures, documentation, or the system itself.

According to the FDA,

“The purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. Verifying or validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device failures. One of the most important quality system elements is the corrective and preventive action subsystem.”

CAPA comprises of two elements: Corrective Actions, and Preventive Actions.

Corrective Actions

The actions that an organization takes to eliminate nonconformities for preventing their reoccurrence. Any corrective action shall be taken without any ado. Also, the actions taken shall be effective enough over the effects of the nonconformities identified.

Preventive Actions

The actions that an organization takes to eliminate the possible causes of the potential nonconformities to prevent problem occurrence well-in-advance. The actions taken shall be effective enough to restrict the effects of potential problems.

Now that you understand the concept of CAPA in detail, it’s time to bring in the discussion about the 5 MOST COMMON Reasons that result in Problems with CAPA Management along with the possible solutions.

The five important reasons why there are problems with CAPA implementation:

•  No Cross-Functionality
•  Being Reactive, Not Proactive
•  Over usage vs Under usage
•  Poor Root Cause Identification
•  Poorly Defined CAPA Process

No Cross Functionality

CAPA is generally a process that medical device companies own for their quality functions. Quality is actually responsible to determine when exactly CAPA is needed as it plays a vital role in the implementation and effectiveness of the quality management system.

Is it justified for a quality function to categorize the nonconformities as CAPA without considering all the aspects and inputs? Definitely not!

Do organizations collect data and information from the resources to take decisions on categorization? It is doubtful due to a lack of transparency and commitment among the departments.

In fact, most of the medical devices company don’t have their trustworthy source of truth that could enable them to make informed decisions.

Being Reactive, Not Proactive

In the majority of the nonconformity’s occurrences, there have been reactions to resolve them rather than adopting any preventions to restrict their occurrences by eliminating the possible causes. It is not the case with medical device companies, it is, unfortunately, the case with every other industry including automotive.

The reactive approach is not a long-term solution because organizations are preparing for the nonconformities to happen while they should identify the ways to prevent nonconformities from happening.

The medical device company doesn’t have easy access to all the data sources, which keeps them at lagging position, not on leading.

There is a need for systems that can help identify issues before they transform into bigger problems for end users as well as companies.

Over Usage Vs Under Usage

Over usage is yet another significant and systemic problem that medical device companies encounter in CAPA.

You can understand the concept of over usage with an example. Let say, you receive a complaint in a product, or you encountered a nonconformance. Will this much of information be enough for declaring the event as CAPA.

This is the most commonly observed issue with CAPA management as medical device companies create a lot of CAPAs over time to review and resolves while many issues don’t even need much attention or investigation.

It is an agreeable situation that under-usage or ignoring the early signs of the problems can result in bigger troubles. This indicates the need for an effective CAPA Software that can perform complete data analysis to identify the early signs backed with similar cases that happened before.

Poor Root Cause Identification

Root cause determination is the significant step, at the same time, one of the biggest concerns related to CAPA.

Defining the absolute root cause takes a good amount of time and efforts. It cannot be defined easily. However, there are many techniques to drill down to the right root cause. The best and most favorite among all is 5 Whys. Let’s have an example of how it works.

An example here could be –for an error that caused a part to be made that did not fit into the machine assembly:

• Why did the part not fit? – The part was too small.

•  Why was the part too small? – The measurements were incorrect.

•  Why were the measurements incorrect? – The mechanical engineer did not take down the dimensions correctly.

•  Why didn’t he take down right dimensions? – Because his tools were not calibrated properly.

•  Why his tools were not calibrated properly? – Because of his ignorance.

After the 5 Whys approach, a company needs to refer to cross-functional resources to have confirmed information about the root cause(s).

Having great tools and CAPA management software improves the root cause determination, which will result in an effective CAPA process in the longer run. Make sure you don’t ignore the root cause aspect to keep all your quality management effective.

Poorly Defined CAPA Process

Defining the CAPA process is often a huge issue especially for the medical device’s companies. Companies, in fact, don’t have any idea about managing the CAPA process effectively. The root cause of ineffective CAPA process lies in its poor-definition of the resources and actions.

You must make sure that the CAPA process is appropriately defined and communicated to your employees or the people involved so that right action(s) can be taken at right time through a well-structured workflow.

What is A Possible Solution?

Firstly, it is important for organizations to realize that CAPA is something cross-functional in nature. Having a cross-functional team to review and report the quality issues especially the ones qualify for the CAPA process. Such a team is commonly referred to as MRB i.e. Management Review Board that includes a representative from every team including quality, operations, manufacturing, and regulatory.

The MRB team can keep the frequency of their reviews as weekly and closely review every issue – be it addressed through customer complaints/feedback, internal audits, or nonconformances reports.

The goal of the MRB team is to review, assess, evaluate, correct, prevent, and control quality issues while documenting all the relevant information. However, documenting all the details manually is not feasible. It is sensible to go for CAPA Management software for medical devices that enables organizations to store as much as CAPA information and documentation they want.

Additionally, a CAPA software ensures a properly defined process with optimum use of resources to mitigate risks and possibilities of non-conformances.

Wouldn’t you like to make your quality management system and processes more effective? Integrate ISO 9001 quality management software like Qualityze in it today!