English COPY Flashcards
Concerning Error management policy all are true except:
Generates a culture of awareness — not blame
Formal logging of errors, results of investigation, action taken
Senior/supervisory staff must not take note of reports and follow the procedure for formal notification and investigation
except
All staff have a responsibility to report errors
Basis of Success of EQA Schemes includes :
Confidentiality of individual report
Identify satisfactory performers in groups/ individuals to identify trends
Concerning GMP all are true except:
A) Quality, safety and efficacy must be designed and built in the product.
B) Testing alone can be relied on to ensure quality.
C) Each step in the manufacturing process must be controlled to ensure that the final product within limits and specifications.
D) It is concerned with both production and quality control
1
Quality, safety and efficacy must be designed and built in the product.
Each step in the manufacturing process must be controlled to ensure that the final product within limits and specifications.
It is concerned with both production and quality control
except
B) Testing alone can be relied on to ensure quality.
Concerning Validation process:
is the specific activity performed to ensure that, following evaluation, new procedures/material work as required
Complaints and Recall system requires:
REpeat mistake
Review and analysis of problems without settling Corrective and preventive action
Concerning External quality assessment (EQA) all are true except:
A) Restrain performance improvements and hold back high standards of practice
B) encourage use of standard reagents/methodology and trained personnel
C) Identify common errors
D) Provide mechanisms to remedy deficiencies revealed
E) Facilitate information exchange & Support accreditation
