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

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The Audit ProcessThe Audit Process

Characteristics of a Good Auditor cont’dSummary

A good auditor should be a guide, philosopher and a friend.

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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

D. Keane June 2005 23

Templates for Meeting RequirementsTemplates 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