1. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
What Exactly is Audit ?
Copyright Alan Rowley Associates 2006
Introduction

2. Quality Assurance Dr Alan G Rowley
SASA Otober 2001
Quality Assurance Dr Alan G Rowley
Based on recognised
quality management
system standard
Quality Policy based on
Quality Objectives
Quality Management
System
Audit
Document system, defined responsibilities
and procedures
Communicate and Implement
Monitor to ensure system is implemented and being followed by all.
Copyright Alan Rowley Associates 2006
Introduction

3. Copyright Alan Rowley Associates 2006

4. Copyright Alan Rowley Associates 2006

5. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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
Introduction

6. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Types of Audit
Tracks sample through system and looks at all components as they interact with sample
Looks at Individual System Components
VERTICAL
HORIZONTAL
Copyright Alan Rowley Associates 2006
Introduction

7. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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
Introduction

8. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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
Introduction

9. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Vertical Audit
Scope of the audit is defined by range of documentation for interacting systems.
Copyright Alan Rowley Associates 2006
Introduction

10. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Vertical Audit
Follows sample through system from receipt to report
Operator Identified
Locate Raw Data
Equipment Identified
Receipt in Laboratory
Sample receipt record, contract review
Copyright Alan Rowley Associates 2006
Introduction

11. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Vertical Audit
Follows sample through system from receipt to report
Report
Compliant/Reflects Raw Data
QC Valid
Trained
Calculations Checked
Calibrated/Working
Operator Identified
Locate Raw Data
Equipment Identified
Copyright Alan Rowley Associates 2006
Introduction

12. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Role of the Auditor
Be clear about the scope of the audit
Defined by documentation
Copyright Alan Rowley Associates 2006
Introduction

13. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Why a plan ?
Role of the Auditor
Read the documentation and plan audit
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
Introduction

14. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Check List (Audit Plan) Content
Identify records to be examined and confirmed
Consider coverage, e.g. percentage, number all ?
Identify activities, equipment, procedures to be observed
Audit Plan
Identify responsible people to be talked to
Identify any conditional actions
Copyright Alan Rowley Associates 2006
Introduction

15. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Can someone follow through
and check observations ?
Quality Auditing Dr Alan G Rowley
Role of the Auditor
Carry out the audit and record the details of systems examined
Report on non-compliances/conformances OBJECTIVELY
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.
Copyright Alan Rowley Associates 2006
Introduction

16. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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
Introduction

17. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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
Introduction

18. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Structure of a Non-conformance Statement
What exactly did you inspect ?
The incubators in Room 101 were inspected to determine whether monitoring and calibration arrangements were in order.
What was being done or not being done which did not comply with the documentation ?
Incubator (Serial No. a/04356) had no calibrated thermometer fitted to permit independent verification of temperature setting.
Copyright Alan Rowley Associates 2006
Introduction

19. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Structure of a Non-conformance Statement
How do you know what should be being done ?
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.
Without this you do not
have a non-compliance
Copyright Alan Rowley Associates 2006
Introduction

20. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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
Introduction

21. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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.
Agree
What 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
Introduction

22. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr Alan G Rowley
Preventive Action
In both ISO 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
Introduction

23. Quality Auditing Dr Alan G Rowley
SASA Otober 2001
Quality Auditing Dr 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.
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Introduction

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What did we see ?
There was an atomic absorption spectrometer in laboratory XYZ standing next to the spectrometer used for routine testing and was apparently available for use.
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What was our concern?
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.
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26. Why is it a non-conformance ?
as required by section 3.1 of NSOP 003.
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27. Copyright Alan Rowley Associates 2006
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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28. Copyright Alan Rowley Associates 2006
Corrective Action ?
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.
Copyright Alan Rowley Associates 2006