Quality Systems
The Quality System that manages issuance, version-control, and archival of documents and records.
What is Document Control?
This PEx principle focuses on delivering value from the customer’s perspective while eliminating activities that do not add value.
What is Lean
PQA
What is Product Quality Architecture?
A visual tool used in quality management used to describe a process in a simple and structured way that helps organizations to:
What is a Process Turtle or Turtle Diagram?
This is a departure from approved written procedures, or an atypical event that falls outside expectations during operations.
What is a deviation?
This documented information describes how your organization intends to meet quality requirements at a system level (quality policy, scope, and key processes)
What is a Quality Manual?
This type of diagram is commonly used in Process Excellence to map each step in a workflow and identify bottlenecks or rework loops.
What is a process map?
MEE
What is Manufacturing Engineering Excellence?
Proactive method for identifying potential failures, assessing their risk, and taking action to prevent or reduce them.
What is an FMEA?
Any systematic process of determining whether a product or service meets specified requirements
What is Quality Assurance?
This ISO standard defines requirements for a quality management system.
What is ISO 9001?
In PEx, this term refers to any activity that consumes resources but does not create value for the customer.
What is waste
DMAIC
What is Define, Measure, Analyze, Improve, & Control?
This tool is used to measure and monitor a company's performance and are among the principal types of process performance indicators.
What is KPIs (Key Performance Indicators)?
A structured review of specific quality management activities that help identify lessons learned that could improve performance on current or future projects
What is Quality Audit?
The Quality System that uses a systematic approach to deal with the transition or transformation of an organization's goals, processes or technologies. The purpose of the approach is to implement strategies for effecting change, identifying inherent risk, controlling change and helping people to adapt to change
What is Change Control or Management of Change?
This continuous improvement cycle is often summarized as Plan, Do, Check, Act.
What is PDCA
DESGN
What is Define, Establish requirements, Select concept, Generate design, implemeNt?
This Japanese term for mistake-proofing refers to designing a process so errors are prevented or immediately detected.
What is Poka-Yoke?
An internal self-assessment, performed to determine the gap between the quality assurance activities needed to ensure that the quality standards are met.
What is Gap Analysis?
This quality system principle says that if an activity wasn’t recorded, it can’t be proven to have happened.
What is “If it isn’t documented, it didn’t happen”?
This methodology uses the DMAIC framework to reduce variation and improve process performance and where the target for perfection is the achievement of no more than 3.4 defects, errors, or mistakes per million opportunities.
What is Six Sigma?
SIPOC
What is Suppliers, Input, Process, Outputs & Customers?
This measurement system analysis study evaluates the amount of variation caused by the measurement device and the operator.
What is a Gauge R&R?
A collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.
What is a Quality Management System (QMS)?