820.25 Personnel
List of names used to verify who is allowed to perform a process.
What is a training addendum?
A written document detailing instructions for making a medical device product.
What is an MP or Manufacturing Procedure?
The control used to identify a product's full identity during all stages receipt, production and distribution.
What is an item or product label?
The design drawing or documentation describing all of the requirements for a material, component, assembly or product.
What is a specification?
A scientific study used to proved a process works.
What is a process validation?
The location where training records are turned in and and filed.
What is Document Control?
A control used by to identify different versions of manufacturing procedures.
What is a Revision Number or Revision Level?
A control used to identify a unique batch of raw materials, assemblies or medical products.
What is the lot number?
A tool used to monitor that the specified TIME required for a process is met.
What is a timer?
A routine equipment service used to ensure manufacturing equipment remains in good repair.
What is a PM or Preventative Maintenance?
The activity of teaching or coaching employees how to perform their jobs properly.
What is Training?
The method used for revising a controlled document or procedure.
What is a Change Request or CR?
Location where an operator records the components used to manufacture a medical device
What is in the the LHR/DHR?
The minimum requirement for when disinfection of manufacturing tables to control microbial contamination occurs.
What is at the beginning and end of shift?
An event of a process being run outside of its Validated Parameters.
What is a Deviation?
A section of a manufacturing procedure identifying the potential product problems they may encounter during the job.
What is Defect Awareness?
The process of teaching associates about upcoming changes before releasing the revised procedure.
What is CR Training?
Reason the traceability of materials used to manufacture a medical device is crucial.
What is to investigate quality problems or concerns?
After using the restroom.
After coughing or sneezing.
Before entering a controlled manufacturing environment.
When should you wash your hands?
This action by manufacturing personnel ensures the Validated process has been used.
What is following the current documented procedure or MP?
An operator or technician responsible to teach others how to do a job.
What is a certified trainer?
All areas must do this on the day a new hard copy specification is issued to them.
What is turn in the obsolete specification before picking up the new one?
Verifying the product label of components before use prevents us from this error.
What is a product/component mix-up?
The process inputs like Time, Temperature, or Pressure required to complete a manufacturing task.
What are process parameters or process settings?
A visual indicator placed directly on pieces of manufacturing equipment that are not yet validated for use.
What is a Lock Out Tag?