Photocopies l Occasionally need uncontrolled copies induction? information for client? l Mark copy as uncontrolled l Explain how in documentation l

PhotocopiesPhotocopies

Occasionally need uncontrolled Occasionally need uncontrolled

copiescopiesinduction?induction?

information for client?information for client?

Mark copy as uncontrolledMark copy as uncontrolled

Explain how in documentationExplain how in documentation

Occasionally need uncontrolled Occasionally need uncontrolled

copiescopiesinduction?induction?

information for client?information for client?

Mark copy as uncontrolledMark copy as uncontrolled


Handwritten AmendmentsHandwritten Amendments

May be permittedMay be permitted


Must be authorisedMust be authorised

All copies must be amended All copies must be amended

MinimiseMinimise

May be permittedMay be permitted


Must be authorisedMust be authorised

All copies must be amended All copies must be amended

MinimiseMinimise

Control of RecordsControl of Records

Documented procedures, records of:Documented procedures, records of:testingtesting

equipment calibrationequipment calibration

internal auditsinternal audits

management reviewmanagement review

corrective, preventive actionscorrective, preventive actions

Documented procedures, records of:Documented procedures, records of:testingtesting

equipment calibrationequipment calibration

internal auditsinternal audits

management reviewmanagement review

corrective, preventive actionscorrective, preventive actions

Control of RecordsControl of Records

What was doneWhat was done

Who did itWho did it

Immediate recordingImmediate recording

PreservationPreservation

Alterations - no erasureAlterations - no erasure

What was doneWhat was done

Who did itWho did it

Immediate recordingImmediate recording

PreservationPreservation

Alterations - no erasureAlterations - no erasure

Internal Audits

OutlineOutline

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

Types of AuditsTypes of Audits

How to meet standard requirementsHow to meet standard requirements

Effective auditing Effective auditing

Preparing for an auditPreparing for an audit

Conducting an auditConducting an audit

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

Types of AuditsTypes of Audits

How to meet standard requirementsHow to meet standard requirements

Effective auditing Effective auditing

Preparing for an auditPreparing for an audit

Conducting an auditConducting an audit

Internal Audits Required:Internal Audits Required:

By ISO 9000By ISO 9000clause 4.17clause 4.17

By ISO/IEC 17025By ISO/IEC 17025clause 4.13 (management requirements)clause 4.13 (management requirements)


By ISO/IEC 17025By ISO/IEC 17025clause 4.13 (management requirements)clause 4.13 (management requirements)

What is an Internal Audit ?What is an Internal Audit ?

Systematic and independent examination of Systematic and independent examination of

the quality management system (QMS)the quality management system (QMS)

By someone within the organisationBy someone within the organisation

In addition to external auditsIn addition to external audits

Systematic and independent examination of Systematic and independent examination of

the quality management system (QMS)the quality management system (QMS)

By someone within the organisationBy someone within the organisation

In addition to external auditsIn addition to external audits

The Internal Audit ProcessThe Internal Audit Process

Scheduled AuditsScheduled Auditsprogramme managed by Quality Managerprogramme managed by Quality Manager

examine documents, results, processesexamine documents, results, processes

identify problemsidentify problems

improve improve

Unscheduled AuditsUnscheduled Auditsinvestigate probleminvestigate problem

improveimprove

Scheduled AuditsScheduled Auditsprogramme managed by Quality Managerprogramme managed by Quality Manager

examine documents, results, processesexamine documents, results, processes

identify problemsidentify problems

improve improve

Unscheduled AuditsUnscheduled Auditsinvestigate probleminvestigate problem

improveimprove

Why Internal Auditing ?Why Internal Auditing ?

Is QMS implemented exactly as intended ?Is QMS implemented exactly as intended ?

To investigate a problemTo investigate a problem

why did it occur ?why did it occur ?

how can it be resolved ?how can it be resolved ?

how can it be prevented in future ?how can it be prevented in future ?

Identify opportunities to improveIdentify opportunities to improve

Does the QMS meet requirements of standards ?Does the QMS meet requirements of standards ?

Is QMS implemented exactly as intended ?Is QMS implemented exactly as intended ?

To investigate a problemTo investigate a problem

why did it occur ?why did it occur ?

how can it be resolved ?how can it be resolved ?

how can it be prevented in future ?how can it be prevented in future ?

Identify opportunities to improveIdentify opportunities to improve

Does the QMS meet requirements of standards ?Does the QMS meet requirements of standards ?

Types of Internal Audits Types of Internal Audits

HorizontalHorizontalall departmentsall departments audited against audited against oneone element of element of

standard or procedurestandard or procedure

VerticalVerticalone departmentone department audited against audited against allall element of standard or procedureelement of standard or procedure

HorizontalHorizontalall departmentsall departments audited against audited against oneone element of element of

standard or procedurestandard or procedure

VerticalVerticalone departmentone department audited against audited against allall element of standard or procedureelement of standard or procedure

Standard Requirements:ISO 9001 and 17025

Standard Requirements:ISO 9001 and 17025

Audit programAudit program

Documented procedures Documented procedures

Auditors independent of activityAuditors independent of activity

Audit results documented and reported to managementAudit results documented and reported to management

Prompt action after problems identifiedPrompt action after problems identified

Follow up activities Follow up activities

Audit programAudit program

Documented procedures Documented procedures

Auditors independent of activityAuditors independent of activity

Audit results documented and reported to managementAudit results documented and reported to management

Prompt action after problems identifiedPrompt action after problems identified

Follow up activities Follow up activities

Management’s ResponsibilityManagement’s Responsibility

Define internal auditing policyDefine internal auditing policy

Assign responsibility of internal audit programAssign responsibility of internal audit programQuality ManagerQuality Manager

Must be advised of internal audit outcomesMust be advised of internal audit outcomesdiscussed at management reviewdiscussed at management review

Define internal auditing policyDefine internal auditing policy

Assign responsibility of internal audit programAssign responsibility of internal audit programQuality ManagerQuality Manager

Must be advised of internal audit outcomesMust be advised of internal audit outcomesdiscussed at management reviewdiscussed at management review

Quality Manager’s Responsibility

Quality Manager’s Responsibility

Establish & maintain internal audit system Establish & maintain internal audit system

Develop scheduleDevelop schedule

Coordinate auditsCoordinate audits

Manage corrective action systemManage corrective action system

Advise management audit outcomesAdvise management audit outcomes

Establish & maintain internal audit system Establish & maintain internal audit system

Develop scheduleDevelop schedule

Coordinate auditsCoordinate audits

Manage corrective action systemManage corrective action system

Advise management audit outcomesAdvise management audit outcomes

Who Audits ?Who Audits ?

Trained & qualified auditors Trained & qualified auditors

Quality Manager selects and trains internal auditorsQuality Manager selects and trains internal auditorsobserver on Quality Manager’s auditsobserver on Quality Manager’s audits

fist audit under supervision of qualified auditorfist audit under supervision of qualified auditor

Independent of the activity to be auditedIndependent of the activity to be audited

Trained & qualified auditors Trained & qualified auditors

Quality Manager selects and trains internal auditorsQuality Manager selects and trains internal auditorsobserver on Quality Manager’s auditsobserver on Quality Manager’s audits

fist audit under supervision of qualified auditorfist audit under supervision of qualified auditor

Independent of the activity to be auditedIndependent of the activity to be audited

Audit ScheduleAudit Schedule

AnnualAnnual

Address all elements of the quality systemAddress all elements of the quality systemnot all departmentsnot all departments

Frequency ?Frequency ?critical areascritical areas

AnnualAnnual

Address all elements of the quality systemAddress all elements of the quality systemnot all departmentsnot all departments

Frequency ?Frequency ?critical areascritical areas

Documents used in Internal Auditing

Documents used in Internal Auditing

ChecklistsChecklists

Corrective action request formsCorrective action request forms

Audit report formsAudit report forms

ChecklistsChecklists

Corrective action request formsCorrective action request forms

Audit report formsAudit report forms

Documenting the Audit Program (1)


Quality ManualQuality Manual

quality policy on internal auditing quality policy on internal auditing

responsibility for internal auditsresponsibility for internal audits

Quality ManualQuality Manual

quality policy on internal auditing quality policy on internal auditing

responsibility for internal auditsresponsibility for internal audits



Internal audit procedure(s)Internal audit procedure(s)

selection and training of auditorsselection and training of auditors

scheduling auditsscheduling audits

responsibilities of auditorsresponsibilities of auditors

preparation, conducting and reporting on auditspreparation, conducting and reporting on audits

identifying, resolving and following up corrective actionsidentifying, resolving and following up corrective actions

reporting audit results to managementreporting audit results to management

Internal audit procedure(s)Internal audit procedure(s)

selection and training of auditorsselection and training of auditors

scheduling auditsscheduling audits

responsibilities of auditorsresponsibilities of auditors

preparation, conducting and reporting on auditspreparation, conducting and reporting on audits

identifying, resolving and following up corrective actionsidentifying, resolving and following up corrective actions

reporting audit results to managementreporting audit results to management

Effective Auditing (1)Effective Auditing (1)

Gather evidence about compliance with Gather evidence about compliance with

quality system or standardquality system or standard

Gather evidence about compliance with Gather evidence about compliance with

quality system or standardquality system or standard

Effective Auditing (2)Effective Auditing (2)

Gather information about:Gather information about:process, operating proceduresprocess, operating procedures

staff, equipment, test methodsstaff, equipment, test methods

environment, handling of samplesenvironment, handling of samples

quality control, verification activitiesquality control, verification activities

recording and reporting practices.recording and reporting practices.

Compare with documented system Compare with documented system

Identify breakdown in system or departure from proceduresIdentify breakdown in system or departure from procedures

Gather information about:Gather information about:process, operating proceduresprocess, operating procedures

staff, equipment, test methodsstaff, equipment, test methods

environment, handling of samplesenvironment, handling of samples

quality control, verification activitiesquality control, verification activities

recording and reporting practices.recording and reporting practices.

Compare with documented system Compare with documented system

Identify breakdown in system or departure from proceduresIdentify breakdown in system or departure from procedures

What to AuditWhat to Audit Systems auditSystems audit

adherence to documented proceduresadherence to documented procedures

Technical auditTechnical auditTechnical correctnessTechnical correctness

adherence to documented procedures/test methodsadherence to documented procedures/test methods

auditor must have technical knowledge of testauditor must have technical knowledge of test

CombinationCombinationvertical auditvertical audit

Systems auditSystems auditadherence to documented proceduresadherence to documented procedures

Technical auditTechnical auditTechnical correctnessTechnical correctness

adherence to documented procedures/test methodsadherence to documented procedures/test methods

auditor must have technical knowledge of testauditor must have technical knowledge of test

CombinationCombinationvertical auditvertical audit

What to Audit - Technical AuditWhat to Audit - Technical Audit StaffStaff

MethodsMethods

EquipmentEquipment

Testing EnvironmentTesting Environment

Samples and Test ItemsSamples and Test Items

Quality ControlQuality Control

ComputersComputers

Records and ReportsRecords and Reports

StaffStaff

MethodsMethods

EquipmentEquipment

Testing EnvironmentTesting Environment

Samples and Test ItemsSamples and Test Items

Quality ControlQuality Control

ComputersComputers

Records and ReportsRecords and Reports

Audit PreparationAudit Preparation Quality Manager determinesQuality Manager determines

audit teamaudit teamlead auditorlead auditor

audit detailsaudit detailsscope of auditscope of audit

time, date, durationtime, date, duration

Contact auditeeContact auditeedate, time, type & durationdate, time, type & duration

Quality Manager determinesQuality Manager determinesaudit teamaudit team

lead auditorlead auditor

audit detailsaudit detailsscope of auditscope of audit

time, date, durationtime, date, duration

Contact auditeeContact auditeedate, time, type & durationdate, time, type & duration

1. Audit Plan1. Audit Plan

4. Gather Evidence 4. Gather Evidence

3. Opening Meeting3. Opening Meeting

5. Record Results5. Record Results

2. Develop Checklists2. Develop Checklists

6. Closing Meeting6. Closing Meeting

7. Audit Report7. Audit Report

Conducting the Audit




1. Audit Plan1. Audit Plan

Objectives & scopeObjectives & scope

Collect documentsCollect documents

standard, procedure, work instructions, formsstandard, procedure, work instructions, forms

desk top reviewdesk top review

HistoryHistory

Objectives & scopeObjectives & scope

Collect documentsCollect documents

standard, procedure, work instructions, formsstandard, procedure, work instructions, forms

desk top reviewdesk top review

HistoryHistory

2. Developing Checklists2. Developing Checklists

GuidelinesGuidelines

Review documentsReview documentsidentify important aspects of the activityidentify important aspects of the activity

list in logical orderlist in logical order

set of questionsset of questions

GuidelinesGuidelines

Review documentsReview documentsidentify important aspects of the activityidentify important aspects of the activity

list in logical orderlist in logical order

set of questionsset of questions

P-AD-0012 3.5 Audit Follow-up Activities P-AD-0012 3.5 Audit Follow-up Activities It may be necessary for a follow-up audit to be performed to verify the

effectiveness of any corrective action carried out. Corrective action, and

subsequent follow-up audits, should be completed within a time period

agreed to by the auditee, in consultation with the auditor.

The Quality Manager should schedule the follow-up audit and enter

details on the Audit Schedule and the Audit Status Log.

It may be necessary for a follow-up audit to be performed to verify the

effectiveness of any corrective action carried out. Corrective action, and

subsequent follow-up audits, should be completed within a time period

agreed to by the auditee, in consultation with the auditor.

The Quality Manager should schedule the follow-up audit and enter

details on the Audit Schedule and the Audit Status Log.

AUDIT CHECKLIST (Reference P-AD-0012) Audit Number: 1 Page1 of1

Reference(clause/procedure)

Question/Requirement Observations Compliance(Y/N)

P-AD-0012 Internal Audits – Follow-up Activities

3.5 When are follow up audits performed ?Why ?

CHECK – are follow-up audits performed ?CHECK – are time periods specified

Where ?In conjunction with auditor ?

CHECK - are follow-ups completed by thespecified time period

Who schedules follow-up audits ?How?

CHECK - are details entered on the: Audit Schedule ?Audit Status Log ?

Document Control:CHECK – are all forms and documents reviewed:

Correct version ?Authorised ?Stored correctly ?

* A = acceptable, NA = not acceptable, NI = needs improvement

3. Opening Meeting 3. Opening Meeting Who ?Who ?

auditor/audit teamauditor/audit team

auditeeauditee

any staff from area to be audited that may be interviewed any staff from area to be audited that may be interviewed

What ?What ? ScopeScope

expected durationexpected duration

Who ?Who ? auditor/audit teamauditor/audit team

auditeeauditee

any staff from area to be audited that may be interviewed any staff from area to be audited that may be interviewed

What ?What ? ScopeScope

expected durationexpected duration

4.1 Gather Evidence about Compliance

4.1 Gather Evidence about Compliance

InterviewsInterviewsask questions about system and its implementationask questions about system and its implementation

who, what, when, how, where, why ?who, what, when, how, where, why ?

other questionsother questionsdirect direct

hypothetical hypothetical

clarifyingclarifying

InterviewsInterviewsask questions about system and its implementationask questions about system and its implementation

who, what, when, how, where, why ?who, what, when, how, where, why ?

other questionsother questionsdirect direct

hypothetical hypothetical

clarifyingclarifying

4.2 Gather Evidence about Compliance4.2 Gather Evidence about Compliance Examine documents Examine documents

procedures, work instructions, forms, quality manualprocedures, work instructions, forms, quality manual

copies controlled ?copies controlled ?

available ?available ?

correct issue status ?correct issue status ?

used in manner intended ?used in manner intended ?

Quality RecordsQuality Records stored correctly ?stored correctly ?

used as objective evidence used as objective evidence

many formsmany forms

Examine documents Examine documents procedures, work instructions, forms, quality manualprocedures, work instructions, forms, quality manual

copies controlled ?copies controlled ?

available ?available ?

correct issue status ?correct issue status ?

used in manner intended ?used in manner intended ?

Quality RecordsQuality Records stored correctly ?stored correctly ?

used as objective evidence used as objective evidence

many formsmany forms

4.3 Gather Evidence about Compliance4.3 Gather Evidence about Compliance Observe activitiesObserve activities

what is said or written may not reflect practicewhat is said or written may not reflect practice““show me”show me”

Examine facilitiesExamine facilitiesas travel through laboratory/officesas travel through laboratory/officesexamine:examine:

equipmentequipmentstandard of housekeepingstandard of housekeepingsize and layout of working areasize and layout of working areaenvironment eg. temperature in labenvironment eg. temperature in lab

Observe activitiesObserve activitieswhat is said or written may not reflect practicewhat is said or written may not reflect practice““show me”show me”

Examine facilitiesExamine facilitiesas travel through laboratory/officesas travel through laboratory/officesexamine:examine:

equipmentequipmentstandard of housekeepingstandard of housekeepingsize and layout of working areasize and layout of working areaenvironment eg. temperature in labenvironment eg. temperature in lab

5. Recording Results5. Recording Results

Record on checklistsRecord on checklistsactivities which do not adhere to quality activities which do not adhere to quality

systemsystem

may be classifiedmay be classifiedmajor non-conformancemajor non-conformance

minor non-conformanceminor non-conformance

areas for improvementareas for improvement

Record on checklistsRecord on checklistsactivities which do not adhere to quality activities which do not adhere to quality

systemsystem

may be classifiedmay be classifiedmajor non-conformancemajor non-conformance

minor non-conformanceminor non-conformance

areas for improvementareas for improvement

6. Closing Meeting(s)6. Closing Meeting(s)

Audit team meetingAudit team meetingdiscuss audit resultsdiscuss audit results

Closing meetingClosing meetingdiscuss corrective actionsdiscuss corrective actions

determine resolution datesdetermine resolution dates

Identify corrective actionsIdentify corrective actionsuse corrective action formsuse corrective action forms

Audit team meetingAudit team meetingdiscuss audit resultsdiscuss audit results

Closing meetingClosing meetingdiscuss corrective actionsdiscuss corrective actions

determine resolution datesdetermine resolution dates

Identify corrective actionsIdentify corrective actionsuse corrective action formsuse corrective action forms

7. Audit Report7. Audit Report

Audit detailsAudit details Summary of findingsSummary of findings

corrective actionscorrective actionsnumberednumberedobjective evidenceobjective evidencereference the documentreference the document

observationsobservations

Distribute Distribute

Audit detailsAudit details Summary of findingsSummary of findings

corrective actionscorrective actionsnumberednumberedobjective evidenceobjective evidencereference the documentreference the document

observationsobservations

Distribute Distribute

Corrective and Preventive Action Corrective and Preventive Action

OutlineOutline

What is a corrective action ?What is a corrective action ?

What is a preventive action ?What is a preventive action ?

Corrective and preventive action Corrective and preventive action

programprogram

Corrective and preventive action processCorrective and preventive action process

What is a corrective action ?What is a corrective action ?

What is a preventive action ?What is a preventive action ?

Corrective and preventive action Corrective and preventive action

programprogram

Corrective and preventive action processCorrective and preventive action process

Corrective & Preventive Action Required:

Corrective & Preventive Action Required:


By ISO/IEC 17025By ISO/IEC 17025clause 4.10 corrective actionclause 4.10 corrective actionclause 4.11 preventive actionclause 4.11 preventive action


By ISO/IEC 17025By ISO/IEC 17025clause 4.10 corrective actionclause 4.10 corrective actionclause 4.11 preventive actionclause 4.11 preventive action

Corrective ActionCorrective Action

An action taken to correct a problemAn action taken to correct a problem

incorrect result incorrect result

departure from proceduredeparture from procedure

An action taken to correct a problemAn action taken to correct a problem

incorrect result incorrect result

departure from proceduredeparture from procedure

Preventive ActionPreventive Action

A A proactiveproactive process to identify process to identifyimprovement opportunitiesimprovement opportunities

potential sources of non-conformancepotential sources of non-conformance

A A proactiveproactive process to identify process to identifyimprovement opportunitiesimprovement opportunities

potential sources of non-conformancepotential sources of non-conformance