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Requirements for Internal Quality Audits

All elements 15 management and 8technical of ISO 15189 should be auditedduring a calendar year.

Must have a procedure for planning andimplementing internal quality audits so as toverify the elements and systems of thequality management system areimplemented and effective.

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Requirements for Internal Quality Audits

Audits should be planned and performed by the Quality Manager/ Officer or nomineeYou cannot audit your own activitiesThe procedure for internal audits should define :-- Audit types vertical/ horizontal to be

performed

- Frequency of these audits (schedule)

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Requirements 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 anagreed time frame

Results of internal audits form part of theQuality Management System review

process

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The Audit Process

What is an audit?It is a planned or documented activity plannedin accordance with written procedures andchecklists, to verify by examination and

investigation of objective evidence, thatapplicable elements of a quality programme or

plan have been developed, documented and

effectively implemented in accordance withspecified requirements.

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The Audit Process

Depth of AuditHorizontal audit (system audit)Will verify that each element of the qualitymanagement system are described,implemented and effective e.g.4.1 to 4.15 155.1 to 5.8 8Total of 23 elements

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The Audit Process (Depth of Audit)

Vertical Audit- Will review in detail the testingdepartments in a laboratory.

- All testing departments should beaudited 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 knownspecimens

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The Audit Process (Depth of Audit)

Vertical AuditThe auditors must consider:-Man (trained, competent, motivated)Materials (traceable, correct type, passed

incoming inspection, correctly used, cleanedetc.)Machine (calibrated, validated, maintenanceQC)Method (clear, up to date, correct version)Mileau (temperature, particulate count,humidity etc.)

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The Audit Process (Depth of Audit)

What are we looking for:-

System audit e.g.4.1 (horizontal)

Vertical audit e.g.

haematologyWhich has more depth horizontal or vertical?

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The Audit Process

Audit process (same for internal, supplier or extrinsic audits):-

Preparation and planningPerformance of the auditExit meetingAudit reportFollow up

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The Audit Process

Audit PlanningAudit schedule (12 month plan) horizontaland vertical is issued to LaboratoryManagementAppoint trained personnel to perform theaudits lead auditor (independent)

Notify the auditee at least 1 week inadvance. Confirm in writing the timetableand personnel involved

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The Audit Process (Planning)

Identify, obtain and review all relevantdocumentation prior to the audit relevantto the scope of the audit.- previous audit reports (follow up)- quality manual- proceduresDevelop audit checklist or have them pre

prepared for horizontal or vertical audits.The audit checklist controls the continuityand depth of the audit.

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The Audit Process (Performance)

Entry meeting (2 mins):-- Introductions- Confirm purpose/ scope

- Timetable including time for exitmeeting

- Confirm escorts for duration of the audit

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The Audit Process (Performance)

1 hour to 1 dayObtain objective evidence to verifycompliance/ non compliance and documentsame on checklist documentation.

Questions should be asked to illicate fullresponse.Following completion of the audit and beforethe closing meeting the audit team will meetto evaluate the evidence and agree on nonconformances found and their classification.A list of non compliances is then made.

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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 andaccepts the findings.

- agree date for the final release of theaudit report.

- agree dates for close out of nonconformances

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The Audit Process

Audit ReportThe formulation of the audit report mustcontain:-- cover sheet.- a report sheet with corrective action

report and agreed action and close outdates.

- non conformances (corrective actionrequests) including classification.

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The Audit Process

Audit Report contd General observations should be notedincluding:-

a) areas audited b) activities found satisfactoryc) activities with concerns

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The 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 withinthe agreed time frame.

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The Audit Process

Characteristics of a Good AuditorGood knowledge of the activity beingauditedCommunication skills (articulate)

Objective (stick to the facts)Open mindedGood listener

ObservantA process approachMeticulous

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The Audit Process

Characteristics of a Good Auditor contd ImpartialProfessional

DiplomaticHigh degree of integrityPatient

Self driven and disciplinedThe auditor should never be aggressive nomatter what happens

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The Audit Process

Characteristics of a Good Auditor contd SummaryA good auditor should be a guide,

philosopher and a friend.

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The Audit Process

Number of Trained AuditorsAt least one per disciplineAuditors must write their own reports and

follow up the close out of corrective actions

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Templates for Meeting Requirements

Templates provided are:-Template 1 Internal Quality Audit ScheduleTemplate 2 Internal Audit Report Lead

SheetTemplate 3 Checklist for Vertical AuditTemplate 4 Checklist for Horizontal Audit