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Copyright Alan Rowley Associates 2006
1
Quality AuditingDr Alan G Rowley
Copyright Alan Rowley Associates 2006
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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
Copyright Alan Rowley Associates 2006
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Copyright Alan Rowley Associates 2006
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Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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 ?
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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.
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
Vertical Audit
Scope of the audit is defined by range of documentation for interacting systems.
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
Vertical Audit
Follows sample through system from receipt to report
Sample receipt record, contract review
Receipt in Laboratory
Operator Identified Equipment IdentifiedLocate Raw Data
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
Role of the Auditor
Be clear about the scope of the audit
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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 ?
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
Structure of a Non-conformance Statement
How do you know what should be being done ?
Without this you do not
have a non-compliance
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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 ?
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.
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
Structure of a Non-conformance Statement
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.
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
Role of the Auditor
Agree on corrective action
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.
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
Role of the Auditor
Agree on corrective action
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 ?
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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.
Copyright Alan Rowley Associates 2006
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Quality AuditingDr Alan G Rowley
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.
Copyright Alan Rowley Associates 2006
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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 ?
Copyright Alan Rowley Associates 2006
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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.
Copyright Alan Rowley Associates 2006
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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 ?