CAPA Process Questions
The Quality Manager and a representative from Global Supply Chain, Regulatory Affairs and R&D are part of what group?
Who are the CAPA Review Board?
This is the organization that performs our external quality audits to confirm compliance to regional regulations and international standards.
What is BSI (The British Standards Institution)
This is the document title of the procedure that now governs the Design Control process.
What is Design Control Procedure?
Name the cloud-based software management system we are migrating to for document control.
What is Veeva.
This form is used to determine the calibration and maintenance required for equipment
What is WIN0037 Equipment Criticality and Risk Assessment
This request must be submitted and approved prior to exceeding the phase due date.
What is an extension?
Quality audits are conducted to measure and evaluate the performance of this - not the performance of people.
What is process (or QMS or procedures)
EDX has a local supplemental instruction to the Global Design Control procedures. This is the document number of the instruction.
What is QMS0022
This day was designed to increase worldwide awareness of the important contribution that quality makes towards both organizational and national growth, and prosperity.
What is Quality Day
These 3 digits are given to equipment.
What is the unique equipment identifier.
The CAPA Review Board is a required approver for this phase.
What is the executive summary?
You should do (or say) this if an auditor asks you a question you don't know the answer to or is outside your scope of expertise.
What is to say so or direct the auditor to the governing procedure or suggest a more appropriate person to answer the question. Note: Always answer questions truthfully and concisely (don't overelaborate.)
The Global Design Control process was implemented in September of this year. The plan to implement this new process was approved and detailed in this type of quality record.
What is a Quality Plan (Project Quality Plan or PQP)
A method for identifying the root cause of a problem by repeatedly asking 'why' is called...
These specifications are listed in Annex A
What are pipette calibration specifications
This phase cannot be extended.
What is the initiation phase.
You are not responsible for memorizing the Quality Policy, but you should be familiar with it and know where to find it. The Quality Policy can be found here
What is the local Controlled Docs electronic folder, cards, and/or various locations with in the facility.
Training to Global procedures such as the Global Design Control procedures is administered and maintained by this Bio-Rad software application.
What is the Learning Management System (LMS)
Name the European Union regulation applicable to in vitro diagnostic medical devices.
What is IVDR.
These people are responsible for equipment management.
Who is the equipment owner, operations leader, and QA.
This process is for reviewing CAPA phase documentation so that decisions are based on sound, credible bases.
What is a technical review?
This person is our local Management Representative for the Quality Management System.
Who is Daniel Cuevas (refer to QMS0001, section 5.5.2)
This Design Control plan ensures upfront agreement and alignment across functions on the design and development approach, key activities, timing, and interfaces.
What is the Design and Development Plan (DDP)
A method for identifying the root cause of a problem by repeatedly asking 'why' is called
What is the 5 Whys method.
These records shall be maintained in the appropriate equipment file for 10 years
What are customer notifications