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 collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.
What is a Quality Management System(QMS)
This is a departure from approved written procedures, or an atypical event that falls outside expectations during operations.
What is a deviation?
This documented guide outlines an organization’s quality policies, 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 Excellence
This type of audit is completed by an external source to ensure compliance to processes and procedures
What is an ISO audit or external audit
Any systematic process of determining whether a product or service meets specified requirements
What is Quality Assurance?
This acronym describes the process of correcting a problem, finding its root cause, and preventing it from happening again.
What is CAPA?
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 manages implementation of modifications to product processes, equipment, and utilities.
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 systematic approach helps 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 Management of Change?
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.
What is Six Sigma?
SIPOC
What is Suppliers, Input, Process, Outputs & Customers
The system 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