Corrective and Preventive Action Series
Part One - Corrective and Preventive Action
Corrective and Preventive Actions (CAPA) are key elements to any management system that
is focused on continual improvement and enhancing customer satisfaction.
It is important to consider these two sub-components when building a new management
system based on any standard, or revising an existing one. In order to do this, one must
understand the Corrective and Preventive Action and the specific focus each one requires
of the organization. Implementation of CAPA, when applied properly, is the path to
improved effectiveness of your organization's management system.
Discover how an effective CAPA process can improve your business and enhance customer
satisfaction. This pre recorded webinar will provide you with an overview of the CAPA
process and proven techniques which you can use to achieve that result in measurable
improvement to your organization.
Participants will develop an understanding of:
- Consideration of CAPA process
- Pitfalls that cause non-conformities during an audit
- Examples of CAPA best practice
- Linking nonconformities to the CAPA system
- The closed loop process
Part Two- Characterizing the Problem and Assembling the Right Team
Characterizing the Problem and Assembling the Right TeamEnsuring you have properly
characterized the problem and assembled the right team are crucial steps in the CAPA
process. Miss a critical player or overlook an important aspect and it could result in
failure creating an analysis "black hole" that could prove to be very costly before you
realize what has happended.
The situation must be properly evaluated to determine a sense of urgency and then the
level of action required. You need to document specifically why the problem is a concern
and what the impact to the company and/or customers may be.
A lot is at stake in the early stages and how you address the problem from the start
will say a lot to your customers and management.
You will learn about evaluation techniques to identify:
- Potential impact of the problem
- Risk to the company or its customers
- Risk and approach to containment and taking of immediate action
- Remedial action that may be required
We will examine nonconformity scenarios and how to avoid creating an analysis "black
hole" that could be very costly.
Part Three- Corrective and Preventive Action - Investigate & Research the Problem
and Identify Root Cause
This may arguably be the most critical step in the Corrective and Preventive Action
process. Virtually every standard and regulatory mandate requires that an organization
take action to eliminate the cause(s) of nonconformities in order to prevent recurrence.
A detailed investigation of the circumstances that created the problem is required. The
elimination of the actual Root Cause of the problem is the only means to prevent the
issue from reoccurring. As a result, many problem solving techniques have been developed
to help in this phase of the process.
Join us as we discuss how to identify the root cause and share with you globally
accepted best practices.
In this webinar you will learn about:
- Effective Root Cause Analysis tools
- Follow a defined investigation strategy
- Ensure you have the key resources in place
- Methods to review all possible circumstances and data that could have contributed to the problem
- Identifying and avoiding treating symptoms and get to the actual cause
Part four - Corrective and Preventive Action - Action Plan, Implementation,
While finding the root cause is important, proper implementation and maintenance of the
action plan to eliminate the cause(s) is even more critical because this is where all of
the required tasks listed and described in the Action Plan are to be initiated,
completed, and documented. Needed changes to documents, processes, procedures, or other
system modifications should be described in this phase, and timely modifications and
communications must take place.
Without proper implementation, success of long term corrective action is in jeopardy and
the problem could reoccur.
In this next module of our CAPA series we will cover best practices related to:
- Action Plan implementation
- Document specification changes
- Process, procedure, or system changes
- Training needs analysis
- Follow-up and verification
- Documenting to meet regulatory requirements
- Data tracking
John DiMaria is the ISO Product Manager for BSI Group America Inc. He has 28 years of
successful experience in Management System Development, including Information Systems,
and Quality Assurance. John is responsible for overseeing, product roll-out, and
client/sales education. He is a product spokesperson for BSI Group America, Inc.
regarding all product standards covering Risk, Quality, Sustainability and Regulatory
Mr. Raj Sivasankar. Raj is Product Manager for BSI's GRC Solutions in the Americas.
He is responsible for new product features / functionality related to Performance ,
Document and Knowledge Management, Audit & Compliance Management, and Risk and
Incident Management. Raj holds a Master in Computer Science from the University of
Missouri, Kansas City and has over 15 years of experience in the IT industry with almost
10 years in various Product Management roles.