Month: October 2021

What does it mean to create a risk-based CAPA process? How should companies go about it? Companies can create a risk-based CAPA process and be compliant with the latest revision of ISO 13485:2016 updates to ISO 13485. A key question many ask is, how do you convert what you have into…

Inspectional Objectives Decision Flow Chart Narrative Medical Device Reporting Inspectional Objectives Decision Flow Chart Narrative Corrections & Removals Inspectional Objectives Decision Flow Chart Narrative Medical Device Tracking Inspectional Objectives Decision Flow Chart Narrative Corrective and Preventive Actions (CAPA) Inspectional Objectives Verify that CAPA system procedure(s) that address the requirements of…

No matter the industry, if you are a member of a Quality Affairs team, you know that a Corrective and Preventive Action (CAPA) system provides a wealth of information regarding the quality of your organization’s products and processes. However, few companies fully leverage the power of this tool to realize…

So this pandemic that started in March 2020 has really disrupted the lives of everyone, but one thing that hasn’t changed is the need for food safety. Food safety is a priority for customers, specifiers, brand owners and ultimately for consumers. The challenges that the pandemic brought about were immediate.…

A successful food safety culture is the product of individual and group values, attitudes, competencies and patterns of behavior that determine the commitment to, and the style and proficiency of the food safety management system. Senior management should plan for the development and continuing improvement of a food safety culture.…

Throughout the 21st century, it is estimated that the number of foodborne illnesses increased due to continual change in production methods, processes, and practices, as well as by changes in consumption habits. According to World Health Organization (WHO), an estimated 600 million—nearly 1 in 10 people worldwide—fall ill after eating…

For Food Safety 2.0 the purpose has to come from within, knowing that everyone (food industry workers) assumes their share of responsibility to ensure that people don’t fall ill or die from consuming unsafe food. Responsible food workers have to do it every day, even when no one is watching!…

For companies engaged in the manufacture or distribution of food products ensuring food safety is a key business activity. Most food companies have the basic elements of food safety, but fail to view these discrete elements as components of a comprehensive food safety system. Because of this narrow view of…

Last month we reached out to our readers to ask about what they consider some of their most important food safety KPIs and tell us about the different reports they are preparing on a regular basis. 15 active people responded to our blog post and we got a lot of…