19.07.01 audit Flashcards
Define audit (according to iso 9000:2015
the systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
External audits examples
MHRA, UKAS, HTA, Health and Safety Executive and participation in external quality assessment schemes
Internal audit
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
Purpose of audits
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
What happens in an audit
Compare reality with requirements. A self declaration of conformity. Continual process
What can an audit identify?
Areas for change and improvement.
What can an audit help achieve
Implementation of policies and guidelines. Help monitor consistency of performance (comparing actual performance to a benchmark). Identify non-conformities.
What is a vertical audit
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.
What is a horizontal audit
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.
Witness or examination audit
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.
Advantages of a vertical audit
Shows how the process operates as a whole. Helps to determine the effectiveness of the quality system and associated processes.
Technical audit
Check of all elements associated with a chosen examination or process are implemented.
Clinical audit
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.
Adhoc audit
Unscheduled audits if there is a reason to doubt the effectiveness of the quality system or validity of test results.
Other types of audits
- Environmental cleanliness
- Health and safety (COSHH, Risk assessments, PPE, waster procedures)
- Fire safety
- Equipment
- User satisfaction
5 principles that underlie the work of auditors
- 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)
Attributes of an auditor
Ethical, open-minded, diplomatic, observant, versatile, self-reliant and impartial.
Audit records should include
An audit schedule, staff undertaking audits are trained, audits and outcomes should be accurately recorded. Outcomes should be acted on and communicated with staff
What should be included in a complete record of an internal audit
- 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.
