Controlled Chaos
This type of document must be reviewed and approved before use and kept up to date.
SOPs
This ensures you can trace who changes a document and why.
Change control
This activity ensures equipment works correctly before being used in production.
Calibration or verification
QMS stands for...
Quality Management System
This process identifies potential hazards and how to reduce them.
Risk assessment
Central Biomedia's retention time for records.
25 years
This process is required for handling customer dissatisfaction or reported product issues.
Complaints
This is the quantity of tiers CBI has for incoming device components.
4
This evaluates whether an SOP was read and understood.
Competency questions
Name 5 of the annual safety trainings held.
fire, chemicals, slips/trips/falls, freezer egress, CPR/AED, lifting, steam, tornado
When referring to data integrity, "Enduring" refers to what.
Available for the required duration.
CAPAs are required to start with this investigation step.
Determining the root cause
CBI documents this to ensure that personnel can consistently perform critical tasks.
Proficiency maintenance
These Quality checks ensure that personnel training programs are effective and procedures are being followed.
Internal audit
The 3 factors used to calculate the RPN.
When referring to data integrity, "Attributable" refers to what.
Clearly linked to the individual who created it
In a CAPA investigation, this tool evaluates whether the chosen corrective action fully addresses the root cause rather than the symptom.
Effectiveness verification
21 CFR 820 is being updated to what international standard.
ISO 13485
Before a supplier can be approved, they must complete this.
Supplier Questionnaire
A risk reduction is only mandatory for what severity values.
9 and 10
The Data Integrity SOP number
LAW068
These are the 5 steps to assess for a change control.
Risk analysis, verification/validation, safety, document change, customer notification
The difference between validation and verification.
Validation- focuses on ensuring the product or system meets the user's needs and intended use.
Verification- refers to evaluating and confirming that a product, system, or component meets specific requirements.
When it comes to Proficiency Maintenance at Lenexa, what are 5 of the 6 tasks that require quarterly completion.
Gel clot, turbidimetric, filter integrity, aspirator bottle, sterility, L7 cleaning
How many number pest control stations are there?
23