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AUDITING IN THE MICROBIOLOGY AUDITING IN THE MICROBIOLOGY LABORATORYLABORATORY

Lyndon ThomasSenior Scientific Officer

Biological TestingNATA

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Auditing Auditing –– What We Will CoverWhat We Will Cover

• The purpose of an internal audit• The requirements of AS ISO/IEC 17025 in relation

to internal audits• Audit schedule• How to prepare for an audit• How to conduct an audit• Types of auditing – vertical vs horizontal• Auditing a microbiology laboratory

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What is an internal audit?What is an internal audit?

“A service involving an independent review of anorganization's records, operations and procedures to evaluate for efficiency, effectiveness, compliance andthe existence of adequate internal controls to mitigaterisks to the achievement of the organization'sobjectives.”

University of Toronto

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What is an internal audit? (ContWhat is an internal audit? (Cont’’d)d)

• Known as a first party audit.• Auditor generally belongs to the organisation.• Auditor has “inside” knowledge of the processes,

policies and general culture or “psyche” of the organisation.

• Audit will generally be conducted against a predetermined plan.

• Audit may cover just one method or procedure or a whole process.

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The purpose of internal auditsThe purpose of internal audits

• Internal audits are all about continual improvement of the overall laboratory processes.

• “The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.” Clause 4.10 Improvement – ISO/IEC 17025:2005

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The purpose of internal audits (ContThe purpose of internal audits (Cont’’d)d)

• Internal audits can be conducted as –

– A planned event according to a schedule

• “The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and this International Standard”.Clause 4.14.1 – ISO/IEC 17025:2005

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The purpose of internal audits (ContThe purpose of internal audits (Cont’’d)d)

• Or, internal audits can be conducted as –

– A result of a process in the laboratory that has resulted in nonconforming testing or calibration and requires immediate and long term solutions.

– Of importance in both situations is to investigate the findings of the audit report to a depth that allows the root cause of any determined problems to be determined.

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The requirements of ISO/IEC 17025 in The requirements of ISO/IEC 17025 in relation to internal auditsrelation to internal audits

“ The internal audit programme shall address all elements of the management system, including the testing and/or calibration activities.”

“It is the responsibility of the quality manager to plan and organise audits as required by the schedule and requested by management.”

“Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.”

Clause 4.14.1 ISO/IEC 17025:2005

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Audit scheduleAudit schedule

• The most critical and failure-prone activities should be covered most frequently.

• Schedule can be structured to fit in around peak workload times throughout a year.

• Audit schedule can be simply documented as a matrix plan with audits set by month.

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MONTH → J F M A M J J A S O N D

Activity to be audited ↓

Organisation and

managementX

Staff/training records X X

Equipment X X

Proficiency programs X X

Test methods X X

Calibrations X X

Sample receipt X

Example of an Audit Schedule

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The auditing processThe auditing process

1. Contact auditee2. Prepare checklists and plan3. Briefing (entry meeting)4. Actual audit – information gathering5. Preparation of report6. Briefing (exit meeting)7. Action on findings8. Follow up audit if required

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The auditing process (ContThe auditing process (Cont’’d)d)

• Remember –– Audits are of the system as a whole and not the person.

• Prepare thoroughly for the audit

• Use checklists – Checklist that is generic and covers standard issues.– Checklist that is tailored around the procedure to be

audited.– Checklist that is as a result of a document review.

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The auditing process (ContThe auditing process (Cont’’d)d)

• Gather sufficient evidence to substantiate the findings in the report.

• Record the particular examples that were reviewed.

• Have a look at work in action if possible – this can establish if there are inconsistencies between actual procedure and work in practice.

• Types of questions to use –– What would you do if….?– I’m not quite sure what you mean by that. Could you perhaps

explain it another way?– Is this always done this way?

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The auditing process (ContThe auditing process (Cont’’d)d)

• Listen actively.

• Be reassuring when necessary.

• Bring the auditee back on track when necessary.

• Always be clear of what you are hearing – if necessary ask for clarification.

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The auditing process (ContThe auditing process (Cont’’d)d)

• Report writing

– Remember to give praise where praise is due.

– Make the findings constructive and definitive.

– The findings must be based upon actual fact and evidence sighted during the audit.

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Follow up on auditsFollow up on audits

• Corrective actions – designed to fix up the non conformance that has already occurred– Remember to get to the root cause of why the non

conformance actually occurred.

• Preventive actions – to prevent non conformances occurring by taking appropriate action where there could be potential for an issue to arise.

• Set realistic timeframes for addressing the findings.

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Types of auditsTypes of audits

• Horizontal –– "This examines one element in a process on more than one

item. It is a detailed check of a particular aspect of the documentation and implementation of the quality management system or examination processes" (Burnett 2002)

• Examine a number of laboratory reports, to evaluate whether appropriate interpretation and suggestions for follow-up of abnormal results had been provided.

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Types of audits (ContTypes of audits (Cont’’d)d)

• Vertical –– "Examines more than one element in a process, on one

item. It is a detailed check that all elements associated with a chosen examination (test) are implemented. In any single audit, one or a number of examinations that have recently passed through the laboratory are randomly selected" (Burnett 2002)

• Select a sample and its associated request form (input), and follow every element of the process to the report (output). This simultaneously audits the process and the traceability.

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A micro auditA micro audit

• Vertical audits can be more valuable because they can encompass more ground.

• Pick a report and work backwards or pick samples from the sample receipt stage and work forward.

• From a NATA perspective a valuable tool to use in conjunction with the internal audits is the ISO/IEC 17025 Standard.

• Another valuable tool (particularly for NATA accredited laboratories) is the Biological Testing Field Application Document.

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A micro audit (ContA micro audit (Cont’’d)d)• Things to look for in such an audit –• e.g. Membrane filtration for Escherichia coli in water

– Arrival conditions of sample – are there temperature requirements?

– Was the temperature recorded?– Was the chain of custody form completed correctly?– Was the sample preparation for testing carried out as per

the laboratory method or standard method?– Are the correct reference cultures being used in the method

and traceable to a recognised source?– Is the media used able to be traced back to the date of

preparation, the manufacturer, the sterility results etc?– Can it be determined that the plates were incubated for the

correct length of time?

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A micro audit (ContA micro audit (Cont’’d)d)

– Was the thermometer used to monitor the temperature of the incubator calibrated?

– Was the correction factor for the thermometer applied if applicable?

– Is the method used the latest standard method available?– Is the membrane filtration equipment in good condition?– Can it be determined that the plates were incubated for the

correct length of time?– Were the results transcribed correctly from the worksheet

into the report?– Were the results checked by a second person?– Were the results reported within the reportable range for

the method?– Does the report contain all the necessary requirements as

per the Standard requirements?

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SummarySummary

• Standards have requirements concerning internal audits that must be complied with.

• Always prepare in advance for internal audits.• Remember that auditing is about the system and not

the person.• Ensure that there is always sufficient evidence

before raising a finding• Audits can be done via various techniques.• Internal audits are about continual improvement of

the overall system.