Internal Quality Audits 4 14 ISO 15189 Requirements

Internal Quality Audits (4. 14) - ISO 15189 Requirements for Internal Audits The Audit Process Templates for Meeting Requirements D. Keane June 2005 1

Requirements for Internal Quality Audits l All elements 15 management and 8 technical of ISO 15189 should be audited during a calendar year. l 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 2

Requirements for Internal Quality Audits l Audits should be planned and performed by the Quality Manager/ Officer or nominee l You cannot audit your own activities l The procedure for internal audits should define: - Audit types vertical/ horizontal to be performed - Frequency of these audits (schedule) D. Keane June 2005 3

Requirements for Internal Quality Audits l 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 frame l Results of internal audits form part of the Quality Management System review process D. Keane June 2005 4

The Audit Process What is an audit? It is a planned or documented activity planned in accordance with written procedures and checklists, to verify by examination and investigation of objective evidence, that applicable elements of a quality programme or plan have been developed, documented and effectively implemented in accordance with specified requirements. D. Keane June 2005 5

The Audit Process Depth of Audit l Horizontal 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 – 15 5. 1 to 5. 8 – 8 Total of 23 elements D. Keane June 2005 6

The Audit Process (Depth of Audit) l 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 7

The Audit Process (Depth of Audit) l 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 8

The Audit Process (Depth of Audit) System audit e. g. 4. 1 (horizontal) What are we looking for: Vertical audit e. g. haematology Which has more depth horizontal or vertical? D. Keane June 2005 9

The Audit Process Audit process (same for internal, supplier or extrinsic audits): l Preparation and planning l Performance of the audit l Exit meeting l Audit report l Follow up D. Keane June 2005 10

The Audit Process Audit Planning l Audit schedule (12 month plan) horizontal and vertical is issued to Laboratory Management l Appoint trained personnel to perform the audits – lead auditor (independent) l Notify the auditee at least 1 week in advance. Confirm in writing the timetable and personnel involved D. Keane June 2005 11

The Audit Process (Planning) l l 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 prepared for horizontal or vertical audits. The audit checklist controls the continuity and depth of the audit. D. Keane June 2005 12

The Audit Process (Performance) l 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 13

The Audit Process (Performance) l 1 hour to 1 day l Obtain objective evidence to verify compliance/ non compliance and document same on checklist documentation. l Questions should be asked to illicate full response. l 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. l A list of non compliances is then made. D. Keane June 2005 14

The Audit Process (Performance) Exit Meeting (5 mins) l The lead auditor controls the exit meeting. l 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 15

The Audit Process Audit Report l The 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 16

The 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 17

The Audit Process Follow up l Quality Assurance Manager/ Officer/ Nominee verifies actions are closed out within an agreed time frame. l Upgrade to major if not closed out within the agreed time frame. D. Keane June 2005 18

The Audit Process Characteristics of a Good Auditor l Good knowledge of the activity being audited l Communication skills (articulate) l Objective (stick to the facts) l Open minded l Good listener l Observant l A process approach l Meticulous D. Keane June 2005 19

The Audit Process Characteristics of a Good Auditor cont’d l Impartial l Professional l Diplomatic l High degree of integrity l Patient l Self driven and disciplined l The auditor should never be aggressive no matter what happens D. Keane June 2005 20

The Audit Process Characteristics of a Good Auditor cont’d l Summary A good auditor should be a guide, philosopher and a friend. D. Keane June 2005 21

The Audit Process Number of Trained Auditors l At least one per discipline l Auditors must write their own reports and follow up the close out of corrective actions D. Keane June 2005 22

Templates for Meeting Requirements Templates provided are: Template 1 – Internal Quality Audit Schedule Template 2 – Internal Audit Report Lead Sheet Template 3 – Checklist for Vertical Audit Template 4 – Checklist for Horizontal Audit D. Keane June 2005 23