copyright alan rowley associates 2006 1 quality auditing dr alan g rowley

Copyright Alan Rowley Associates 2006

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Quality AuditingDr Alan G Rowley


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Quality AssuranceDr Alan G RowleyQuality Policy based on

Quality Objectives

Quality Management System

Communicate and Implement

Document system, defined responsibilities and procedures

Monitor to ensure system is implemented and being

followed by all.

Audit

Based on recognisedquality management

system standard


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Role of the Auditor

Be clear about the scope of the audit

Read the documentation and plan the audit.

Carry out the audit and record the details of systems examined

Report on non-conformances OBJECTIVELY

Agree on corrective action


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Types of Audit

VE

RT

ICA

L

HORIZONTAL

Tracks sample through system and

looks at all components as they interact with sample

Looks at Individual System Components


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TECHNICAL AUDIT

Critical examination of a technical procedure to determine whether it is being performed as per documentation.

Frequently relates to methods.

Technical auditor will ask questions about method-evaluate suitability ?


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Horizontal Audit

Scope of the audit is defined by documentation for specific system.

E.G. Equipment management, training and qualifications control, document control etc.

May be chapter in Quality Manual, SOP, external documentation.


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Vertical Audit

Scope of the audit is defined by range of documentation for interacting systems.


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Vertical Audit

Follows sample through system from receipt to report

Sample receipt record, contract review

Receipt in Laboratory

Operator Identified Equipment IdentifiedLocate Raw Data


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Vertical Audit

Follows sample through system from receipt to report

Operator Identified Equipment IdentifiedLocate Raw Data

Trained

QC Valid

Calculations Checked

Calibrated/Working

Report Compliant/Reflects Raw Data


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Role of the Auditor

Be clear about the scope of the audit


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Role of the Auditor

Read the documentation and plan audit

Why a plan ?

Provides a structure and boundaries for audit

An audit is a SAMPLE check list formalises sample

Discourages ‘no stone unturned’ approach

Serves as useful part of record of audit coverage


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Check List (Audit Plan) Content

Identify records to be examined and confirmed

Consider coverage, e.g. percentage, number all ?

Identify responsible people to be talked to

Identify any conditional actions

Audit Plan

Identify activities, equipment, procedures to be observed


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Role of the Auditor

Carry out the audit and record the details of systems examined

Can someone follow through and check observations ?

Record as much detail as possible.

Room numbers, equipment identifiers, sources of information.Identify possible non-conformances and note objective evidence, i.e. What you observed.

Assign non-conformances to specific document reference.

Report on non-compliances/conformances OBJECTIVELY


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Structure of a Non-conformance Statement

What exactly did you inspect ?

What was being done or not being done which did not comply with the documentation ?


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How do you know what should be being done ?

Without this you do not

have a non-compliance


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What exactly did you inspect ?

What was being done or not being done which did not comply with the documentation ?

The incubators in Room 101 were inspected to determine whether monitoring and calibration arrangements were in order.

Incubator (Serial No. a/04356) had no calibrated

thermometer fitted to permit independent verification

of temperature setting.


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How do you know what should be being done ?

Without this you do not

have a non-compliance

Section 6.3 of the laboratory Quality

Manual states that all temperature

controlled equipment must be fitted with a

dedicated calibrated thermometer to permit

verification of the temperature setting.


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Role of the Auditor


The main requirement is to agree corrective action addressing the ‘root cause’, i.e. likelihood of recurrence is reduced/eliminated and quality system IMPROVED.

Initial ‘fix’, sometimes called ‘correction’ of non-conformance. This is not ‘corrective action’. Corrective action changes procedure to make it more secure and so IMPROVES quality system.


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Role of the Auditor


The main requirement is to agree corrective action addressing the ‘root cause’, i.e. likelihood of recurrence is reduced/eliminated and quality system IMPROVED.

AgreeWhat will be done.Who will be responsible for ensuring it is done.When it will be done by

What will be done to monitor effectiveness ? Follow-up Audit ?


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Preventive Action

In both ISO 17025 and ISO 9001

Preventive action is pro-active. Nothing has gone wrong yet but an opportunity to improve the quality system has been identified or potential for a non-conformance to develop has been spotted.

Auditors may be asked to provide suggestions for preventive/improvement action, normally by identifying possibilities for strengthening the quality system in the area audited.


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Preventive Action/Suggestions for Improvement

Auditors should only offer suggestions if asked for.

Preventive/Improvement action suggestions must be kept separate from non-conformance reports.

Corrective action in response to non-conformances is compulsory. Management has discretion on preventive/improvement action through the proportionate response provision.


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There was an atomic absorption spectrometer in laboratory XYZ standing next to the spectrometer used for routine testing and was apparently available for use.

What did we see ?


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The spectrometer was reported by the management to be undergoing commissioning trials but was not labelled to indicate this and to show it was not to be used.

What was our concern?


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as required by section 3.1 of NSOP 003.

Why is it a non-conformance ?


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There was an atomic absorption spectrometer in laboratory XYZ standing next to the spectrometer used for routine testing and was apparently available for use.

The spectrometer was reported by the management to be undergoing commissioning trials but was not labelled to indicate this and to show it was not to be used.

as required by section 3.1 of NSOP 003.


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Corrective action might be to issue a reminder to all senior staff of the segregation/labelling requirement and to ask that the Quality Manager carry out a check audit the next time new equipment is being commissioned.

Corrective Action ?

copyright alan rowley associates 2006 1 quality auditing dr alan g rowley

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