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.
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!
