Design Control
Identifies the key customers, gathering their requirements, and expressing those requirements in a measureable way
What are stakeholder requirements
Serves as the new electronic platform for the Bio-Rad Quality Management System (eQMS). This digital solution aims to optimize and elevate the management of key quality processes within our company.
What is Veeva Vault eQMS
This type of bar graph is commonly used to show frequency distributions, or how often each different value in a set of data occurs
What is a histogram
This type of audit is performed by BR colleagues to another BR site to ensure compliance to processes and procedures
What is an internal audit
This document follows the manufacturing process and requires operators to record data upon completing tasks
What is a batch record/master formula
Statement of WHAT the various stakeholders of the product need in terms of features, functions, performance, constraints, and quality, written in terms of what the product must do or qualities it must have.
What is a design requirement ( Also called product requirement)
Document Management, Change Control, CAPA, Non Conformity, Audit
What are the modules in Veeva
A simple root cause analysis tool that involves repeatedly asking questions to drill down to a root cause
What is the 5-why or why-why
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
This Japanese term refers to the philosophy of continuous improvement in manufacturing settings. These events typically take place over 3-5 days.
What is Kaizen
Establishing by objective evidence that device specifications conform to user needs and intended uses during conditions of use, transportation, and storage.
What is Design Validation
The Journey to One QMS Starts Here
What is the Greensky program
A statistical approach to an experiment in which different variables are tested
What is design of experiments (DOE)
This type of audit involves a customer coming to review a specific product line
What is a customer audit
This metric measures the percentage of products that meet quality standards without any nonconformities
What is right the first time (RFT)
A document that records the relationship between inputs, requirements, test procedures, test results, essential outputs etc.
What is traceability matrix
a powerful feature that enables multiple users to edit documents simultaneously in microsoft
What is collaborative authoring
This type of chart studies how a process changes over time. It also compares data to control limits.
What is a control chart
This document summarizes any audit findings/nonconformance's
What is an audit report
This visual tool maps out the flow of materials and information in a manufacturing process to identify waste
What is Value Stream Mapping
The intended device use and/or misuse, the needs of the users and/or patients, the effects of user interface design, job aiding, and personnel training on the operation, maintenance, and installation of equipment.
What is Human Factors Engineering
This feature allows to get document number and enter the relevant document, project and product information before creating the document draft
What is a Placeholder
This method uses a structured approach to problem-solving and continuous improvement, often associated with Six Sigma.
What is DMAIC (Define, Measure, Analyze, Improve, Control)
This document is commonly asked for in audits and outlines the organizations quality policy and objectives
What is the Quality Manual
A systematic approach used to identify potential failure points in a process and determine what their effects are to product quality
What is Failure Mode and Effects Analysis (FMEA)