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

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

Copyright Alan Rowley Associates 2006

Copyright Alan Rowley Associates 2006

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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. Copyright Alan Rowley Associates 2006 Introduction

Copyright Alan Rowley Associates 2006 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. Copyright Alan Rowley Associates 2006

Copyright Alan Rowley Associates 2006 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. Copyright Alan Rowley Associates 2006

Why is it a non-conformance ? as required by section 3.1 of NSOP 003. Copyright Alan Rowley Associates 2006

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. Copyright Alan Rowley Associates 2006

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