Summary: The CAPA (Corrective and Preventive Action) process provides a six-step framework for identifying non-conformances, determining root causes, implementing corrections, and preventing recurrence — making it one of the most powerful tools available for reducing cost of poor quality (COPQ). Required under ISO 9001 Clause 10.2, FDA cGMP (21 CFR Part 820), and IATF 16949, […]
According to recent survey data, 68% of staff say they don’t feel completely safe at work. Reasons vary — some are worried about risks to their health from airborne contaminants or caustic materials, and others are concerned about environmental issues such as working conditions and procedural risks. Still, others point to safety concerns around current operations that could put their lives and livelihoods at risk. […]
The supply chain management landscape has changed significantly over the past two years. As noted by Supply Chain 24/7, 84% of enterprise CFOs now see supply chain disruptions as moderate or severe risks. And even if suppliers don’t experience shortages or work stoppages, getting goods where they’re going is more expensive.
Transportation costs may increase by 600% compared to pre-pandemic levels. This increase is dependent on the origin and destination of goods, as well as the mode of transportation used.
The result? Supplier diversification. Companies, large and small, now understand the danger of relying on one supplier and have started using multiple suppliers. With more suppliers, however, comes more complexity, in turn creating a need for more robust supplier management. […]
Summary: OSHA Forms 300, 300A, and 301 serve different roles in injury and illness recordkeeping: Form 301 captures the incident details, Form 300 logs each recordable case, and Form 300A summarizes annual totals for posting and review. For safety and compliance teams, understanding how these OSHA forms connect is essential for accurate reporting, deadline compliance, […]
Health and safety are everyone’s business. Companies that make safety a shared responsibility across front-line staff, managers, and C-suite executives are better equipped to identify, quantify, and remediate key issues. One key component in creating a safety culture is the Safety Observations Report. By documenting potentially unsafe practices and processes on-site, organizations can create action plans to address these issues — before they cause loss of productivity or serious harm. […]
Summary: The EU Corporate Sustainability Due Diligence Directive, or CSDDD, requires large companies to identify, prevent, mitigate, and address human rights and environmental harms across their value chains. For procurement and supply chain leaders, CSDDD makes supplier due diligence a legal requirement rather than a voluntary ESG initiative, which raises the need for better risk […]
Hazards and risks are interconnected. Both represent potential problems for companies if workers are injured as a result of preexisting hazards or risks, the results could have both short- and long-term implications on health and safety. It’s worth noting, however, that while hazards and risks are similar, they’re not the same thing. […]
Summary: An ISO audit is a systematic, independent evaluation of your organization's practices against internationally recognized standards for quality management, environmental management, or information security. For QA Managers, Quality Directors, and Lead Auditors, ISO audits validate that quality management systems are functioning effectively and drive measurable improvements in non-conformance rates, audit completion rates, and time […]
Summary: A SMETA audit is a practical way to evaluate supplier labor practices, health and safety, environmental controls, and business ethics within one widely accepted framework. For supply chain and procurement teams, SMETA audits create documented due diligence, improve supplier transparency, and support compliance with growing ESG and global supply chain regulations such as CSDDD, […]
Summary: Quality control inspections — including pre-production, in-line, final, and incoming inspections — verify that products meet established standards at every stage of the manufacturing process. For QA Managers and Quality Engineers tracking first pass yield (FPY), cost of poor quality (COPQ), and non-conformance rates under ISO 9001, IATF 16949, or FDA cGMP, implementing the […]
Certainty Software is a proven solution for any audit/inspection based performance improvement program in virtually all sectors of the economy from global Fortune 500 multinationals in food manufacturing to leading national companies in the hospitality sector.
Email: info@certaintysoftware.com
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