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Quality Improvement can be distinguished from Quality Control in that Quality Improvement is the purposeful change of a process to improve the reliability of achieving an outcome. Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome.
The scientific method is an example of a continual improvement process. A continual improvement process, also often called a continuous improvement process (abbreviated as CIP or CI), is an ongoing effort to improve products, services, or processes. [1] These efforts can seek "incremental" improvement over time or "breakthrough" improvement all ...
Performance is a measure of the results achieved. Performance efficiency is the ratio between effort expended and results achieved. The difference between current performance and the theoretical performance limit is the performance improvement zone. Another way to think of performance improvement is to see it as improvement in four potential areas:
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
Lean Six Sigma is a process improvement approach that uses a collaborative team effort to improve performance by systematically removing operational waste [1] and reducing process variation. It combines the many tools and techniques that form the "tool box" of Lean Management and Six Sigma to increase the velocity of value creation in business ...
ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
The question of whether performance differences are quality differences may depend on circumstantial preferences-but preferences based on functional requirements, not taste. Some performance standards are based on subjective preferences, but the preferences are so universal that they have the force of an objective standard.
It is used for product or process design in contrast with process improvement. [1] Measurement is the most important part of most Six Sigma or DFSS tools, but whereas in Six Sigma measurements are made from an existing process, DFSS focuses on gaining a deep insight into customer needs and using these to inform every design decision and trade-off.