GDP
Shall not be used on any quality record.
What is Correction fluid or Correction tape?
Product that does not meet specifications.
What is Non-conforming Product?
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 Thermo Fisher colleagues to another Thermo Fisher 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
According to GDP, any corrections to documents must follow this method, where the original entry is still readable after the correction.
What is the Single Line Cross-Out?
This standard ensures adherence to quality standards
What is ISO?
A simple root cause analysis tool that involves repeatedly asking questions to drill down to a root cause
What is the 5-why or PSP?
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
This GDP guideline requires that every entry in a document is made in real time at the moment the activity is performed.
What is Timeliness?
Deliver our responsibilities; Execute on the promise; People and talent.
What are our Imperatives 2024?
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)
Writing "As above", or symbols, such as ditto marks ("), or arrows indicating repeated entries.
What is not allowed?
SQP
What is the Site Quality Plan?
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
GDP requires that documents must be stored in a manner that ensures they are secure, retrievable, and protected from loss or damage.
What is Document Control?
based on six key pillars to help drive reliability improvement across our Operating Companies.
What is the Danaher Reliability System?
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)