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Quality Management Software is a category of technologies used by organizations to manage the delivery of high-quality products. Solutions range in functionality, however, with the use of automation capabilities they typically have components for managing internal and external risk, compliance, and the quality of processes and products.
Risk-based inspection (RBI) is an optimal maintenance business process used to examine equipment such as pressure vessels, quick-opening closure - doors, heat exchangers, and piping in industrial plants. RBI is a decision-making methodology for optimizing inspection plans.
Risk is the potential of losing something of value, weighed against the potential to gain something of value. Risk hinders the achievement of objective and it has two attributes. Likelihood: Probability of Risk Event (P) Consequences: Impact of Risk Event (I) In Risk based internal auditing two types of risks are considered. Inherent risk
Essentially, the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the Plan, Do, Check, Act cycle in a process-based approach but is now further encouraging this to have risk-based thinking (section 0.3.3 of the introduction). The purpose of the quality objectives is to determine the conformity of the ...
Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. [1] Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. [2]
Taxonomy-based risk identification – The taxonomy in taxonomy-based risk identification is a breakdown of possible risk sources. Based on the taxonomy and knowledge of best practices, a questionnaire is compiled. The answers to the questions reveal risks. [21] Common-risk checking [22] – In several industries, lists with known risks are ...
Domain specific GRC vendors understand the cyclical connection between governance, risk and compliance within a particular area of governance. For example, within financial processing — that a risk will either relate to the absence of a control (need to update governance) and/or the lack of adherence to (or poor quality of) an existing control.
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 ...