Auditing Flashcards
What is an internal audit
A documented quality improvement exercise in which evidence is gathered systematically and independently, and evaluated to determine whether audit criteria are fulfilled for example;
1. compliance with lab policies and procedures,
2. compliance with external standards
Auditing identifies areas of non-conformities and improvement and measures the efficacy of the QMS
Giving users and the lab confidence in the system and provides evidence of due diligence
What is a clinical audit
Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through a peer-led systematic review of care against explicit criteria i.e. evidence-based standards
What is the purpose of auditing and how the effectiveness measured?
To improve practice; re-auditing may be required to confirm that improvements to practice have taken place
What are the main stages of an auditing process?
- Selecting a relevant topic
- Agree the standards of best practice i.e., audit criteria
- Collect data on current practice
- Analyse the data against the standards and feedback results
- Implement change if needed
What elements make up the Quality Management System in a Genetic Testing Laboratory
Management organisation Documents Continual improvement and quality assurance Test processes Resources External services
What is the consequences of failing to perform audits?
A drop in standards of pratice may lead to errors affecting patient care
The lab could get sued
Lose accreditation status
Lose business and funding
What are the auditing standards?
ISO15189:2012 Standards
25 main standards and 98 sub-category standards
What categories of audit exist?
First party – those you do internally to inspect own system
Second party - inspect a (potential) supplier for satisfaction with their system to provide products or services
Third party – carried out by an independent external auditor (e.g. UKAS) working for an accredited body to determine compliance to standards
What types of internal audits are there?
Vertical
Examination/witness
Horizontal
What is a vertical audit?
Examines all stages of a process and all of the variables that may affect any aspect of processes. Gives an overview of how the system works as a whole.
All aspects are checked in the samples pathway
i.e., user info, request form, transport,
sample storage, disposal,
specimen reception, SOPs, equipment,
IQC, EQA, staff training, reporting, authorisation, TATs
What is an examination or witness audit?
Examines the person undertaking the task to ensure whether the SOP is fit for purpose, is the individual trained (CPD records), has the process been validated
What is a horizontal audit
Examines one element in a process on more than one item .e., one specific standard is looked at in detail
What requirements does a SOP need to fulfill
ISO 15189:2012 requirements
What qualities make a good auditor?
Members of staff from an independent area of work provide a fresh pair of eyes
Auditors should be fair, ethical and honest
Conduct an audit within a no-blame educational culture
Evidence-based approach, recording evidence
What are examples of audit non-conformities?
Documents:
The SOP was not reviewed on scheduled date
An unauthorised copy of an authorised SOP was found
The copy of the SOP being used in the lab is an old version
Staffing
A staff member does not have a competency form adequately completed
A staff member has not had an appraisal in the last year
