Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project… your strategy requires QMS oversight.
QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.
Are Corrective Actions More Important Than Preventive Actions?
Although CAPA is a necessary part of a proper Risk Management process, for some reason small companies tend to ignore Preventive Actions and prefer to concentrate only on Corrective Actions. Ignoring preventive actions might sound like saving money at first, but not investing resources into improving company processes will undoubtedly cost more on a long term. The price of preventive actions turns out to be pretty cost-effective, especially if you consider the amount you might spend on correcting the same mistakes over and over again. Not improving processes and not investigating the root causes of hazardous events will inevitably lead to frustration and a bad reputation.
Implement Preventive Actions After Each Corrective Action
ISO 14971 clearly guides to understand it’s not enough just to correct the already existing hazard, preventive actions have to be implemented after each corrective action. The second, but not the less important step toward compliance, is documenting all risk management activities. The collected information about hazards and the following actions that were taken have to be documented and stored in CAPA documentation. If the Company regularly performs risk assessment and CAPA actions after each design and development stage, and as well as when any non-conformance appears, it would significantly decrease the production and post-production costs and additionally contribute to process improvement and product quality.
Preventive Actions are Future Cost Savings
Implementing preventive actions will not just save time, effort and money, but it will also improve company processes that drive the quality of your products, and that’s one of the main
principles of QMS.