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call this Compliance 2 which compared with Compliance 1 is analogous to the difference between total quality management (TQM) and quality control & assurance (QC/QA), or Safety 1 and Safety 2 from the safety domain

improvement has expanded, along with the LEAN tools and practices, to other areas of the business such as: quality

Over the last decade Lean tools and practices have expanded to consider quality, safety, and environmental This toolkit provides practical strategies and techniques to: “improve Lean results—waste elimination, quality

You're likely juggling safety regulations, security requirements, sustainability goals, quality standards When safety protocols don't align with security measures, or when quality controls conflict with sustainability coordination Domain-Specific Modules Safety Management Systems Security Operations Sustainability Programs Quality

However, many will also discover their quality, security, safety, sustainability, or environmental outcomes If you want to make a qualitative difference to compliance outcomes you need a compliance program and

Enhanced production processes simultaneously improve compliance outcomes like safety and quality. When you enhance production quality, you simultaneously strengthen quality compliance. When you enhance production efficiency or operational delivery, do compliance outcomes like safety and quality

Just as we have seen quality and safety become more performance and risk-based the same shift is happening It will more akin to Total Quality Management (TQM) where better environmental outcomes are designed

Edwards Deming, “You cannot inspect quality into a product.” stated, inspecting what has already happened is too slow and too late to ensure risk does not become a reality Quality, safety, environmental, regulatory, and other compliance programs help to rebuild trust by reducing It is only by anticipating, planning, and acting that prevents risks from becoming a reality.

topic of much discussion these days and is considered by some to be a proactive measure against safety, quality

In 2005, the Quality Risk Management program ICH-Q9 was introduced to bring a risk based approach to A design space establishes parameters that have been demonstrated to provide quality assurance. management system should include the following, as appropriate for the stage of the lifecycle: (a) Quality However, from a pharmaceutical quality system standpoint, all changes should be evaluated by a company to confirm the change objectives were achieved and that there was no deleterious impact on product quality

cannot "react" your way to better outcomes in the same way that you cannot inspect your way to better quality You will be with those that want to see: better outcomes, improved safety, increased quality, appropriate

At the same time, understanding how to identify risks embedded in quality, health and safety, and environmental have criticized ISO for using the phrase "risk-based thinking" in their ISO 9001:2015 revision of the quality As many have commented about quality, you cannot inspect your way to quality – you need to design it