19.07.01 audit

Question 1

Define audit (according to iso 9000:2015

Answer 1

the systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Question 2

External audits examples

Answer 2

MHRA, UKAS, HTA, Health and Safety Executive and participation in external quality assessment schemes

Question 3

Internal audit

Answer 3

provide evidence to demonstrate quality assurance through evaluation of the quality management system, implementation of improvement processes and ensure that examination processes are being conducted to agreed procedures and correctly performed

Question 4

Purpose of audits

Answer 4

Provides an ongoing evaluation and improvement of quality management system. Must be independent. Ensures the service provided by lab meets needs and requirements of users

Question 5

What happens in an audit

Answer 5

Compare reality with requirements. A self declaration of conformity. Continual process

Question 6

What can an audit identify?

Answer 6

Areas for change and improvement.

Question 7

What can an audit help achieve

Answer 7

Implementation of policies and guidelines. Help monitor consistency of performance (comparing actual performance to a benchmark). Identify non-conformities.

Question 8

What is a vertical audit

Answer 8

Examines more than one part of a process on one item. e.g. auditing a sample through the lab from specimen reception to issuing a report. May involve auditing all activity, eg temperature recordings, equipement logs, staff training, dates on chemicals.

Question 9

What is a horizontal audit

Answer 9

examines one part of a process to more than one item.

e. g.
- are all batch documentation readily available at a designated location
- is all equipment calibrated.

Question 10

Witness or examination audit

Answer 10

Examines a person undertaking the task. Ensures compliance with the controlled standard operating procedure (SOP). Witness staff are working competently and safely. Can get feedback on staff training, suggestions for improvement.

Question 11

Advantages of a vertical audit

Answer 11

Shows how the process operates as a whole. Helps to determine the effectiveness of the quality system and associated processes.

Question 12

Technical audit

Answer 12

Check of all elements associated with a chosen examination or process are implemented.

Question 13

Clinical audit

Answer 13

Quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. NICE 2002. How closely local practice resembles recommended practice.

Question 14

Adhoc audit

Answer 14

Unscheduled audits if there is a reason to doubt the effectiveness of the quality system or validity of test results.

Question 15

Other types of audits

Answer 15

• Environmental cleanliness
• Health and safety (COSHH, Risk assessments, PPE, waster procedures)
• Fire safety
• Equipment
• User satisfaction

Question 16

5 principles that underlie the work of auditors

Answer 16

• Ethical conduct (foundation of professionalism)
• Fair presentation (obligation to report truthfully and accurately)
• Professional care (application of diligence and judgment in auditing)
• Independence (basis of impartiality of the audit and of the audit conclusions)
• Evidence based approach (rational method for reaching reliable and reproducible audit conclusions in the audit process)

Question 17

Attributes of an auditor

Answer 17

Ethical, open-minded, diplomatic, observant, versatile, self-reliant and impartial.

Question 18

Audit records should include

Answer 18

An audit schedule, staff undertaking audits are trained, audits and outcomes should be accurately recorded. Outcomes should be acted on and communicated with staff

Question 19

What should be included in a complete record of an internal audit

Answer 19

• Names of auditors
• Date of audit
• Reference number
• Activities, areas or items audited
• Any non-conformances identified.
• Recommendations and timescales for corrective action. Who is responsible
• Date and signature as a confirmation of completion of corrective actions.