Upload
cynthia-miller
View
217
Download
0
Tags:
Embed Size (px)
Citation preview
D. Keane June 2005 1
Internal Quality Audits (4.14)Internal Quality Audits (4.14)
- ISO 15189 Requirements for Internal Audits
- The Audit Process
- Templates for Meeting Requirements
D. Keane June 2005 2
Requirements for Internal Quality AuditsRequirements for Internal Quality Audits
All elements 15 management and 8 technical of ISO 15189 should be audited during a calendar year.
Must have a procedure for planning and implementing internal quality audits so as to verify the elements and systems of the quality management system are implemented and effective.
D. Keane June 2005 3
Requirements for Internal Quality AuditsRequirements for Internal Quality Audits
Audits should be planned and performed by the Quality Manager/ Officer or nominee
You cannot audit your own activitiesThe procedure for internal audits should
define:-- Audit types vertical/ horizontal to be
performed- Frequency of these audits (schedule)
D. Keane June 2005 4
Requirements for Internal Quality AuditsRequirements for Internal Quality Audits
The procedure for internal audits should define:-- Methodology for performing the audit
including reporting and close out processes
- Corrective action/ preventative action must be documented and taken within
an agreed time frameResults of internal audits form part of the
Quality Management System review process
D. Keane June 2005 5
The Audit ProcessThe Audit Process
What is an audit?It is a planned or documented activity plannedin accordance with written procedures and checklists, to verify by examination and investigation of objective evidence, that applicable elements of a quality programme
orplan have been developed, documented and effectively implemented in accordance with specified requirements.
D. Keane June 2005 6
The Audit ProcessThe Audit Process
Depth of AuditHorizontal audit (system audit)
Will verify that each element of the quality management system are described, implemented and effective e.g. 4.1 to 4.15 – 155.1 to 5.8 – 8 Total of 23 elements
D. Keane June 2005 7
The Audit Process (Depth of Audit)The Audit Process (Depth of Audit)
Vertical Audit- Will review in detail the testing departments in a laboratory. - All testing departments should be audited over the course of 12 months. - A vertical audit is designed to cover activities from procurement of specimen to issue of results.- The audit uses the details of 2 known specimens
D. Keane June 2005 8
The Audit Process (Depth of Audit)The Audit Process (Depth of Audit)Vertical Audit
The auditors must consider:-Man (trained, competent, motivated)Materials (traceable, correct type, passed incoming inspection, correctly used, cleaned etc.)Machine (calibrated, validated, maintenance QC)Method (clear, up to date, correct version)Mileau (temperature, particulate count, humidity etc.)
D. Keane June 2005 9
The Audit Process (Depth of Audit)The Audit Process (Depth of Audit)
What are we looking for:-
System audit e.g. 4.1 (horizontal)
Vertical audit e.g. haematology
Which has more depth horizontal or vertical?
D. Keane June 2005 10
The Audit ProcessThe Audit Process
Audit process (same for internal, supplier or
extrinsic audits):-Preparation and planningPerformance of the auditExit meetingAudit reportFollow up
D. Keane June 2005 11
The Audit ProcessThe Audit Process
Audit PlanningAudit schedule (12 month plan) horizontal
and vertical is issued to Laboratory Management
Appoint trained personnel to perform the audits – lead auditor (independent)
Notify the auditee at least 1 week in advance. Confirm in writing the timetable and personnel involved
D. Keane June 2005 12
The Audit Process (Planning)The Audit Process (Planning)
Identify, obtain and review all relevant documentation prior to the audit relevant to the scope of the audit.- previous audit reports (follow up)- quality manual- procedures
Develop audit checklist or have them pre prepared for horizontal or vertical audits. The audit checklist controls the continuity and depth of the audit.
D. Keane June 2005 13
The Audit Process (Performance)The Audit Process (Performance)
Entry meeting (2 mins):-
- Introductions
- Confirm purpose/ scope
- Timetable including time for exit meeting
- Confirm escorts for duration of the audit
D. Keane June 2005 14
The Audit Process (Performance)The Audit Process (Performance)
1 hour to 1 dayObtain objective evidence to verify
compliance/ non compliance and document same on checklist documentation.
Questions should be asked to illicate full response.
Following completion of the audit and before the closing meeting the audit team will meet to evaluate the evidence and agree on non conformances found and their classification.
A list of non compliances is then made.
D. Keane June 2005 15
The Audit Process (Performance)The Audit Process (Performance)
Exit Meeting (5 mins)The lead auditor controls the exit meeting.The exit meeting will focus on:-
- the outcome of the audit- ensure the auditee understands and accepts the findings.- agree date for the final release of the audit report.- agree dates for close out of non conformances
D. Keane June 2005 16
The Audit ProcessThe Audit Process
Audit ReportThe formulation of the audit report must
contain:-- cover sheet.- a report sheet with corrective action report and agreed action and close out dates.- non conformances (corrective action requests) including classification.
D. Keane June 2005 17
The Audit ProcessThe Audit Process
Audit Report cont’d• General observations should be noted
including:-
a) areas audited
b) activities found satisfactory
c) activities with concerns
D. Keane June 2005 18
The Audit ProcessThe Audit Process
Follow upQuality Assurance Manager/ Officer/
Nominee verifies actions are closed out within an agreed time frame.
Upgrade to major if not closed out within the agreed time frame.
D. Keane June 2005 19
The Audit ProcessThe Audit Process
Characteristics of a Good AuditorGood knowledge of the activity being auditedCommunication skills (articulate)Objective (stick to the facts)Open mindedGood listenerObservantA process approachMeticulous
D. Keane June 2005 20
The Audit ProcessThe Audit Process
Characteristics of a Good Auditor cont’dImpartialProfessionalDiplomaticHigh degree of integrityPatientSelf driven and disciplinedThe auditor should never be aggressive no
matter what happens
D. Keane June 2005 21
The Audit ProcessThe Audit Process
Characteristics of a Good Auditor cont’dSummary
A good auditor should be a guide, philosopher and a friend.
D. Keane June 2005 22
The Audit ProcessThe Audit Process
Number of Trained AuditorsAt least one per disciplineAuditors must write their own reports and
follow up the close out of corrective actions