Learning Marketplace

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.

Learning Objectives:

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, and Follow-up

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

Presenters:

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 Compliance.

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.