|More "effective" effectiveness checks
can help you close more CAPAs.
In the final segment of a three-part QEM/CAPA webinar series, quality expert Ken Peterson discusses the importance of effectiveness checks within the CAPA process. He also explains the difference between process verification and process validation, and why knowing which process to use (and when to use it) is paramount to a successful CAPA methodology. Peterson closes the webinar by summarizing the current models and best practices being used in management review, data collection, and charting to enhance CAPA decision making in all areas of your business. This is a summary of that discussion. If you wish to view the webinar in its entirety, please click on the link provided at the end of the post.
A serious quality event that requires a corrective action also requires that the proposed corrective action be checked for efficacy before it is fully implemented into the quality management system; this is done through a process called effectiveness checking. An effectiveness check is the measure and determination that the corrective action has (or has not) eliminated the problem. In the webinar, Peterson presents three reasons for taking a solution through an effectiveness check: to build confidence that the solution will work, to validate that the solution did work, and to minimize any risks or potential problems that might cause reoccurrence.
The overall goal of the effectiveness check is to determine whether or not your solution will eliminate the root cause. As such, there are a few questions that must be taken into consideration:
- What will I measure?
- Will my solution completely remove the root cause?
- Will my solution cause other problems?
- What will this effectiveness check cost?
- What approvals will I need?
While many companies set arbitrary deadlines for performing effectiveness checks, typically between 30 and 60 days after implementation of the corrective action, Peterson recommends using the FDA’s QSIT (Quality Systems Inspection Technique) process as a guide. QSIT advises that a corrective action be verified and/or validated prior to implementation, using a risk-based approach. A risk-based approach to CAPA means that low severity defects, which are not likely to cause patient harm, are put on the back burner while more severe, potentially life-threatening defects are investigated immediately. Every good CAPA process should have a built-in effectiveness checking mechanism to verify and validate that the CAPA system is working properly.
This article is a summary from the Webinar:
Effectiveness Checking and Management Review (CAPA Part 3)
To get the full details please download your free copy.
Verification vs. Validation
An Example of the Verification Process
Quality professionals frequently express confusion about the difference between verification and validation of identified actions. Peterson explains that there are five key elements that make up the verification/validation process: plan, verify, actions, validate, and correct. As illustrated in the diagram at right, verification comes before the corrective action; its purpose is to examine the specifications and build scientific confidence that the output is going to provide the desired result, i.e., eliminate the root cause. This is done by conducting a noninvasive test or experiment. Conversely, validation comes after the corrective action; its purpose is to provide scientific evidence that the changes (i.e., corrective actions) did work. Validation not only saves you the time and expense of deploying a solution that does not or will not work, but also helps you avoid unnecessary disruptions to other processes and resources that are likely to be affected by the corrective action.
|Five elements of the verification/validation process.
To illustrate the verification process in action, Peterson provides an example of a vitamin container whose label keeps falling off. The root cause investigation uncovered an issue with the labeling machine; it ran of glue at the end of each run. The proposed corrective action was to switch to continuous feed pump and rebuild the reservoir to accept a constant flow of glue. To verify this action prior to deployment, a prototype was constructed and tested in a controlled laboratory environment under similar production procedures.
Validation is Your Last Chance to Catch a Problem
Despite having robust processes in place, it is still possible to have unanticipated consequences that would “invalidate” the solution. This is what justifies the time spent on validation. Returning again to QSIT, Peterson points out three questions to consider during the validation process:
You also want to avoid the most frequent mistakes made during CAPA validation: measuring the wrong things, involving the wrong people, and failing to measure for the right amount of time. Most companies allow the validation to run far too long, at a cost to the organization.
Returning to the vitamin container example, Peterson explains that the validation process in this particular scenario would involve running three days of production at various speeds, tracking the data, and confirming that the new pump and reservoir meet specifications, without causing any additional problems.
- Did the corrective and preventive actions adversely affect the finished product?
- Were the corrective and preventive actions effective?
- Did any similar product or quality problems occur after the implementation of the corrective and preventive actions?
Management involvement is critical to maintaining an effective, compliant CAPA system. Once the verification process is complete, the next step is to submit your corrective and preventive actions for management review. Management review closes the CAPA loop, documents the solution, and provides accountability at the management level.
As you develop your routing process, it’s important to remember that the managers are different individuals, often from different departments (e.g., a department manager, a quality manager, a lower-level manager, a senior-level executive, etc.), so it’s critical to identify which manager, or managers, is required to sign off on each particular component.
Another factor to consider is how the information is going to be communicated. Will signatures be required? Will those signatures be collected as e-signatures and stored in an automated system or written signatures filed in a folder? Will the information have to be reviewed at another site? Whether you’re collecting management review data electronically or manually, make sure you provide a place for managers to convey their own observations and notes rather than simply rubber stamping observations made by the CAPA team. After the management review is complete, allow the quality team to provide the final stamp of approval.
The (Often Overlooked) Benefits of CAPA
CAPA touches every part of your quality system, including audits, complaints, inspections, adverse events, suppliers, equipment, change control, document management, and even training requirements, which is why implementing the proper CAPA tools and processes is critical to achieving compliance. Most organizations understand this. However, many organizations fail to consider the benefits of a solid CAPA system beyond compliance. The data gathered during CAPA can be used to improve decision making in other areas of your business, such as manufacturing, marketing, customer satisfaction, and staffing, and ultimately, to help you build market leadership.
To view the webinar in its entirety, click here. The first and second installments of Ken’s webinar are available on our YouTube channel. You may also ask questions and interact with Ken via LinkedIn.
Lisa Weeks, a marketing communications specialist at MasterControl Inc., writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.
(1) Ken Peterson, MasterControl’s director of business development, Quality and Compliance Consulting Team, has helped many organizations (including Abbott Laboratories, Johnson & Johnson, and IBM) come up with new quality management solutions that allow them to achieve enhanced and breakthrough results. He frequently speaks at industry events for organizations such as AAMI, PDA, the American Society for Quality Control (ASQ), Barnett International, The Executive Committee (TEC), and other industry forums. To learn more about Ken Peterson and the QCC, go to: http://www.mastercontrol.com/quality-management-software/quality-control/compliance-consulting.html?lne=lkey