Quality Department (August Update)

How is the Non con-conformance unique reference number allocated??

A number is given to each one from 1 – 1000
Just the initials and the date of the non conformance is given
Initials of the person who noticed the non conformance, day, month and year of the non conformance, Sequential letter for that person for that day. E.g. TC.02.08.2022.A

When a Non conformance is related to a session what details need to be completed on the Potential Non conformance report?

Session date only – no more information is needed
Session date, Session name, Session area and Donor number
Donor number and vets details only

If there is a electronic notification of a product quality issue who needs to be notified?

Customer Service Team are to notify the Lab Manager or Logistics Manager by going to talk to them about it
Customer Service Team to notify the Lab Manager or Logistics Manager using Product Quality Issue Notification Email template FRM/QUA/70
Customer Service Team to notify the Donor Administration Manager or the Marketing Manager using Product Quality Issue Notification Email template FRM/QUA/70

When must drug-related adverse reactions be recorded on the Donor Adverse Reaction Form whilst on session?

For medium to severe reactions only
For all grades of reaction
For severe reactions only

Who must complete the form to advise the Marketing Authorisation Holder of potential drug-related adverse events involving their veterinary/cascade medicines?

PBB Registered Veterinary Nurse
Quality Compliance Officer
PBB Veterinary Surgeon responsible for the session
Clinical Supervisor

You should notify the donor’s registered veterinary surgeon or out of hours provider if the donor has received intravenous fluid therapy or any prescription only medication following an adverse reaction. True or False?

False
True

How can you tell that the SOP that you’re viewing is under validation?

The text is all highlighted in red
There is an "Under Validation" watermark across each page
It will state "(Author initials) Draft Version – Document in Validation in the header and footer

A document which is being used to validate a process can never be printed. True or False?

True
False

Once a CAPA action plan has been approved, it is the responsibility of the Quality Department to communicate the plan out to all relevant personnel via email. True or False?

True
False

When might a minor non-conformance trigger the CAPA process?

If it keeps recurring
A minor non-conformance always triggers the CAPA process
A minor non-conformance will never trigger the CAPA process

A non-conformance record (FRM/QUA/04) doesn’t need to be completed if the non-conformance risk category is under 2. True or False?

True
False

Once a non-conformance record has been completed or has been moved to CAPA who must review the non-conformance?

The Quality Compliance Officer
The Quality Manager
The Managing Director
The Manager or Deputy Manager of the department that the Non Conformance relates to

Quality Department (August Update)

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