Good Manufacturing Practices are a crucial system that should be implemented in all manufacturing plants. They help to guarantee that industrial processes and facilities are properly designed, monitored, and controlled. Companies who follow these guidelines help to ensure the uniqueness, robustness, and quality of their products. When adopted, GMP can help to reduce facility losses and waste while also protecting the company, consumers, and the environment.The FDA establishes the Good Manufacturing Practices, which provide producers in all industries with a set of standards to aspire for. They assist facilities in gaining and retaining the trust of consumers who want to know that the products they buy are created in safe,
Read more · 4 min readAny organization should implement a risk management process. Risk management does not have to be time-consuming or complex for enterprises to implement or for insurance brokers to deliver to their clients. The risk management process can be beneficial with a little formalization, structure, and a deep grasp of the company. Risk management does necessitate some time and money investment, but it does not have to be significant to be effective. It is more likely to be used and maintained if it is gradually deployed over time.Risk management is an important activity because it provides an organization with the tools it needs to detect and manage potential risks. It is easy to
Read more · 4 min readStarting with transforming and strengthening the technical leadership's mindset and respecting the well-being of this team is crucial to creating a sustainable Effective Food Safety Culture in any food processing organization. Recognizing team members' well-being needs to begin with the basics, such as clarifying expectations, providing basic knowledge of tools and systems, and providing opportunities for team members to do their best. Especially considering that 60% of people report saying that they getting even more tasks than they can finish at work. Starting with these basic elements to ensure that team members have manageable workloads and appropriate teams simply makes sense to integrity and well-being. To create an effective culture and maintain that
Read more · 4 min readIATF 16949:2016 provides the international specification and quality management standard for the automotive industry, based on ISO 9001:2015. Rather than being a stand-alone QMS, it is intended to be used in combination with ISO 9001:2015 and includes supplemental requirements specific to the automotive industry. Here are the five most important steps in the internal audit process.The harsh reality is that an internal audit is immensely helpful to a process owner to bring fresh eyes to look closer into the process to find improvement opportunities, thereby assisting in the creation of a faster, more effective, and more efficient process. Continue reading to learn the five basic steps to conducting an internal audit, as
Read more · 4 min readUnderstand the Key Points of Conducting Investigation According to ISO 14155 Good Clinical Practices
The general specifications and requirements for clinical investigations of medical devices are provided by ISO 14155. The standard's most recent version, which was released in 2020, is intended to act as a reference for clinical research professionals when designing, carrying out, documenting, and reporting clinical studies about the security and efficiency of medical devices.The ISO 14155 standard aims to keep the rights, safety, and well-being of human subjects, it ensures scientific conduct of the clinical investigation and credibility of the clinical investigation results and describes the responsibilities of the sponsor and principal investigator. An assist sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical
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