Effectivity Checks the Often Overlooked Requirement of Corrective and Preventive Action Processes

November 4, 2020 from 10:45 am to 11:45 am

Speaker: Linda Mummah-Schendel

Effectiveness checks are often an overlooked tool in the Corrective and Preventive action process. The effectiveness check is performed at the end of the process and does not garner the same emphasis and attention as that of the root cause analysis and the actions to correct or prevent the problems but it can be a valuable tool to ensure obtaining the maximum benefit for the resources spent on the process.

A well-constructed effectiveness check can ensure that the root cause and subsequent actions actually addressed the issue or can provide valuable information to prevent further issues in the future and improve both the solution to the problem and the entire process. There are many approaches that can be taken to improve your process. Effectiveness checks can do all of that and more or it can be a check box activity, written to just close the file. What do you want from your effectiveness checks? There are several approaches and tools to use to improve your effectiveness checks.

Effectiveness checks can also provide both management, customers and regulatory authorities evidence of either a robust, healthy corrective and preventive action process or it can provide evidence that your quality system requires work and management is not as committed to the process as necessary. Examples and case studies will be presented to provide examples, solutions and the information required to assess your current effectiveness checks and improve them in the future. Help your company get the most out of their Corrective and Preventive action systems by creating effective effectiveness checks.

Linda Mummah-Schendel Linda Mummah-Schendel, RAC, CQA, CBA, CQE and CPGP and a senior member of ASQ. During her over 30 years of experience in the regulated industries, Linda has worked for companies in medical devices, combination drug/medical devices, active implantables, IVDs, biopharmaceuticals, dietary supplements, medical foods and food in the areas of research and development, manufacturing, quality and regulatory. Her regulatory experience includes submissions in support of PMAs, 510ks, IDE, Design Dossiers and Technical Files. Her Quality Experience includes Quality Compliance, Design Assurance, Quality Systems, Risk Management, Corrective and Preventive Action and Design Control. Linda has been working for the last seven years for NAMSA providing services to clients to meet their regulatory and quality needs. Linda has also presented several Webinars and presentations on topics such as Quality Systems, Combination Product GMPs, ISO 13485:2016 updates, Medical Device Regulations and Risk Management/ISO 14971.

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