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Welcome to Internal Auditing Training Course
Delegates Introductions
Please introduce yourself Your name A brief description of Education &
Experience. A brief Job description Your involvement in QHSE
Assurance.
Aim
• To provide training for potential auditors and prepare them for that role
• Enable delegates to be aware of QHSE system requirements
• Satisfy the requirement of ISO 9001:2008, 14001:2004 & OHSAS 18001:2007
for auditor training• Enable delegates to be prepared to act as
auditees
Course Structure Lectures and discussions on each topic. Exercises/ case studies to enable
delegates to experience audit practices and report findings.
Ongoing assessment to evaluate delegates’ ability based on participation, teamwork, application and comprehension..
Course competence test - to ensure retention of knowledge of auditing.
Auditor
A person who has the qualification to perform quality audits
• A auditor must be authorized for each audit
• Persons selected as auditor shall be
Free from bias Independent
of the activity being audited
Free from influence
Auditors’ Responsibilities
Comply with auditing requirements Communicate and clarify audit
requirements Plan and carry out assigned
responsibilities Assess effectiveness of quality system Document audit observations Report audit results Co-operate with team and support lead
auditor Maintain confidentiality Retain and safeguard documents Verify corrective action
Additional Abilities
Address searching questions Display an authoritative
presence Think quickly Stand their ground Remain calm and polite When required make
suggestions for improvement
Lead Auditor
An auditor authorised and appointed to manage a quality audit
Duties include:• Assisting with the team selection• Controlling, planning and co-ordinating the audit• Representing the audit team with the auditees
management• Writing and submitting the report
Additional Lead Auditor Tasks
Review quality documentation for compliance to standard
Assess extent of comformance Review contents of teams’
checklists Decide on the validity and
categories of noncompliances Make clear written and verbal
reports to management
Auditor Training
Specialist knowledge of applicable specifications, standards, codes, procedures, industrial practices in the areas to be audited
Ability to manage an audit team An in-depth knowledge of quality
system requirements That they will audit objectively and
thoroughly without bias They have appropriate experience in
the area being audited
Section 2Introduction to Quality
What is Quality ?
What does Quality mean to you ?
What does Quality mean to your organisation ?
Quality
The totality of characteristics of an entity that bear on its ability to
satisfy stated and implied needs
Introduction to Quality
To be successful, an organisation must offer a service and/or products which :-
Meet a well defined purpose or need
Satisfy its users’ / customers’ expectations and contractual requirements
Comply with applicable standards and specifications
Introduction to Quality
To be successful, an organisation must offer a service and/or product which :-
Will yield a profit on the resources invested
Is supplied within delivery timescales agreed / required by the user / customer.
In other words - “Provide a Product and/or Service which is totally fit for the purpose”
Definition: an audit by an organization of its
own systems and procedures Objective:
to assure maintenance, development and improvement of the Quality System
Requirement: ISO 9001; 4.17 guidelines found in ISO 10011
FIRST PARTY (INTERNAL AUDIT)
Definition an audit by organization on
suppliers and sub-contractors Objectives
to determine suitability of suppliers / sub-contractors
to appraise supplier / sub-contractor performance
SECOND PARTY (EXTERNAL AUDIT)
Definition an audit by a body which is
independent of the organization, its suppliers and customers
Objective to determine whether an
organisation’s Quality System has been documented and implemented in accordance with a specified standard
THIRD PARTY (EXTERNAL AUDIT)
Accreditation Scheme
Department of Trade and IndustryDTI
Accredit
Certification BodiesCalibration & Test Houses
Certify
Companies / Organisations
United Kingdom Accreditation ServiceUKAS
EXAMPLES SHOWN FOR UK REGISTRATION
Section 3Quality Management System
Document Control
Typical Documents Requiring Control: the quality manual Procedures Work Instructions including works
orders/route cards Quality Plans Drawing - including “as built” Specifications
Quality Management SystemDocumentation
QualityManual
Quality SystemProcedures Work
Instructions
Forms
Quality Manual
Quality Policy Objectives Overview Organisation Responsibilities Requirements
Policy/Responsibility/Procedure Reference
QUALITY MANUAL CONTENTS
Title page Scope Amendments page Table of contents Introduction to organisation Quality Policy Policies for specific aspects of Quality System Organisation structure Quality system outline Cross-reference to Standard requirements
Title page
Index of procedures
Amendments record
Procedures
Cross-reference to associated
documents
QUALITY PROCEDURES MANUAL
Quality System Procedures
A set of procedures which detail how the requirements of the quality manual are to be implemented
Detailed procedures which define how the processes are to be performed and controlled
Specifying who is responsible for doing what
Department, orFunction, orGroup of functions
Understandable
Useable
Written for
Written In an agreed format
QUALITY SYSTEM PROCEDURES
PROCEDURE FORMAT
PURPOSE
SCOPE
REFERENCES
DEFINTIONS
PROCEDURE/METHODS
ASSOCIATEDDOCUMENTS
Objectives/intention
applicability, boundaries
who, what, where, when,
how
other documents quoted
explain confusing terms
list those referred to / used
who is responsible ?
what is actioned / controlled ?
what methods / equipment / records ?
how is information processed ?
where - location ?
when - timing / frequency ?
PROCEDURE/ METHOD SECTION
Title Number Issue status Page numbers - paginated Approval authority Issuing authority Issue date
ESSENTIAL INFORMATION ON A PROCEDURE
Work Instructions
Detailed Instructions for the performance of specific tasks
Such Instruction may cover Materials Processes Verification
These must be:
documented
implemented
controlled
WORK INSTRUCTIONS
Operating instructions Job cards User manuals Inspection plans/instructions Technical manuals Manufacturer’s
recommendations Performance standards
EXAMPLES OF WORK INSTRUCTIONS
Quality Management System
Sales Design Purchasing Manufacture Accounts Personnel After Sales
Level 1
Level 2
Level 3
Level 4
Quality Manual
Procedures
Work Instructions
Forms
StandardISO 9000
Policy Statement Commitment, Organisation, Responsibilities
Company Practice & Interfaces
Written Instructions to Control Tasks
Quality Records
Documenting Procedures
Say what you do
Do what you say
and where necessary
Show what you did
Document Control Inspection and test plans records Purchasing specifications, orders &
acknowledgements Quotes, tenders, contracts / contract
reviews Audit plans & records Management reviews Design reviews
Document Control Control requirements Responsibility for the creation,
authorization, revision and issuing of controlled documents
Formats to be used Identification of issue, revision for the
change Instructions for removal of superseded
documents
Document control A controlled document is: Properly authorized by approved
signatories Serial numbered for identification Issue/revision referenced and dated Issued within a registered circulation subject to control of all changes Updated to the same distribution
Document Control Uncontrolled document UNCONTROLLED COPY - Will not be
maintained THIS COPY WILL NOT BE KEPT UP
TO DATE CHECK FOR LATEST ISSUE BEFORE
USE
Document Control
Typical Audit Questions Do the documents conform with
statements made in the Quality Manual? Are the appropriate to the user? Do they cover the scope required? Are they properly authorized? Are the responsibilities adequately
defined? Are they communicated to the people
who need them?
Document Control Are they updated when
necessary ? Are there any gaps or overlaps
which could cause confusion? Are interfaces properly defined?
Document Control
Desktop Assessment Are the documents in evidence and
being worked to? Are the documents in evidence
applicable to the activity in which they are being used?
Is the correct issue in use? Are they circulated in a timely manner? Are they superseded or obsolete issues
withdrawn?
DOCUMENTATION MUST BE
Readable
Useable
Accessible
Usually a control document Provides a statement of the
operation Identifies procedures used Defines “hold” points Indicates monitoring process Indicates the record system may be a Level 2 or Level 3
document
QUALITY PLAN
Section 4Introduction to ISO 9001:2000
01. General To address customer satisfaction
by meeting customer and applicable regulatory requirements.
Standard can be use for external/internal parties to audit.
QMS requirements are complementary to technical requirements for product.
0.2 Process Approach Process approach to quality
management encouraged. When used within Quality
Management System it include... Introduces and explain the process
model as conceptual presentation of QMS requirements specified.
Managementresponsibility
Measurement,analysis,
improvement
Resourcemanagement
Product(and/or service)
realization
Customer
Requirements
Customer
Satisfaction
QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT
Fig. 1 Quality Management Process Model
Input Output Product/ Service
ISO 9001:2000 Management
1 Scope 1.1 General
Standard specifies QMS requirements for use .
demonstrate organization’s ability to consistently provide product meeting customer and applicable regulatory requirements.
Address customer’s satisfaction through effective application of the system .
1.2 Application Requirements are generic. Requirements may be excluded in
case of non-applicability Exclusions must:
Not affect ability to provide conforming product.
Be limited to clause 7.
2. Normative reference Replica of present clause 2 Users encouraged to use most
recent revisions. ISO 8402:1994 replaced by ISO
9000:2000,Quality management systems-Fundamentals and vocabulary.
3. Terms and definitions ISO 9000 :2000 applies
3. Terms and definitions “Organization” replaces “Supplier” “Supplier” replaces “Sub-
contractor” The term Product may also refer to
Service.
4. Quality management system
4.1 General requirements Establish,document,implement,maintain
and continually improve QMS in accordance with the standard.
The organization shall identify the process Determine sequence and interaction Determine criteria and methods for
operation and control
Ensure availability of resources and information.
Monitor ,measure and analyze the process
Implement actions necessary
4.2 Documentation requirements
4.2.1 General Documented Policy and Objectives A quality Manual Documented procedures required by the
standard Documents to ensure effective planning,
operation and control of its processes Records
4.2 General Documentation Requirements
Extend Size and type of organization Complexity and interaction of
processes. Competence of personnel.
To Include Documented procedures required by
standard. Documents required by organization to
ensure effective operation and control process.
4.2.2 Quality Manual
Establish and maintain a quality manual which includes
The Scope The documented procedures and
their reference. Description of interaction between
the processes of QMS
4.2.3 Control of DocumentsDocuments shall be controlled A documented procedure shall be
established to define the controls needed
to approve documents for adequacy prior to issue.
to review and update, and re approve documents.
Changes and revisions are identified. Availability of documents at points of
use. Documents are legible and readily
identifiable. Documents of external origin are
identified and their distribution controlled.
Suitable identification of obsolete documents and unintended usage.
Control of Documents (Contd..)
4.2.4 Control of records
Records shall be established and maintained
Documented procedures for identification, storage, retrieval, protection, retention time and disposition of quality records.
5 Management responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality policy 5.4 Planning 5.4.1Quality objectives 5.4.2 Quality Planning 5.5 Responsibility,authority and communication 5.5.1 Responsibility & authority
5.5.3Internal communication
5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output 6.0 Resource Management 6.1 Provision of resources 6.2 .1 general 6.2.2
Competence,awareness and training
6.3Infrastructure 6.4 Work environment
5.1 Management Commitment Top management shall provide evidence
of commitment to the development and improvement of QMS by: Communicating the importance of meeting
customer and legal/regulatory requirements.
Establishing quality policy and objectives. Management Reviews Provision of resources.
5.2 Customer Focus
Customer requirements are met with the aim of enhancing customer satisfaction.
5.3 Quality Policy Appropriate to the purpose of
organization. Commitment to meet requirements and
continual improvements. Frame work for establishing and reviewing
quality objectives. Communicated and understood within the
organization. Is reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality Objectives Establish quality objectives at
relevant functions and levels. Objectives must be measurable
and consistent with the quality policy.
5.4.2 Quality Planning
Planning of Quality Management System to meet the requirement given as well as quality objectives.
Integrity of Quality Management System is maintained when changes occur.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority Define and communicate the
responsibilities and authorities.
5.5.2 Management representative Member of the management who
has responsibility and authority for ensuring that processes of the QMS are
established and maintained. Reporting on performance of QMS including
needs for improvement. Promoting awareness of customer needs
and requirements..
5.5.3 Internal Communication Ensure communication between
various levels and functions regarding the processes of the QMS and their effectiveness.
5.6 Management Review5.6.1 General Review of QMS by top
management at planned interval. Ensure QMS suitability ,adequacy
and effectiveness. Evaluate the need for changes and
improvements to QMS including policy and objectives.
5.6.2 Review InputReview performance and improvement
opportunities related to: Audit results Customer feedback Process performance Product conformance Status of preventive and corrective actions. Follow up actions from earlier reviews. Change that could affect the QMS. Recommendations for improvements.
5.6.3 Review output
Output to include decisions and actions related to
Improvement of QMS and its process
improvement of product resources needs
6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 Assignment of personnel 6.2.2 Training,awareness and competency 6.3 Infrastructure 6.4 Work environment
6.1 provision of resources
Determine and provide To implement and maintain the
Quality Management System and continually improve effectiveness.
To enhance customer satisfaction by meeting customer requirements.
6.2 Human resources
6.2.1 General Those who have responsibilities
defined in the QMS must be competent on the basis of applicable education,training,skills and experience.
6.2 Competence, awareness and training Identify competency needs Provide required training Evaluate the effectiveness of training
provided. Ensure staff aware of relevance and
importance of their activities and contribution to achieving objectives.
Maintain appropriate records education,training,qualification and experience.
6.3 InfrastructureIdentify ,provide and maintain the
facilities needed to achieve product conformity.This shall include
Building, workspace & associated facilities
Process equipment, hardware and software
supporting services.
6.4 Work environment Identify and manage human and
physical factors of the work environment needed to achieve product conformity.
7 Product Realization 7.1 Planning of product realization 7.2 Customer related processes 7.3 Design & development 7.4 Purchasing 7.5 Production & service provision 7.6 Control of measuring &
monitoring devices.
7.1 Planning of realization processesPlan and develop processes for product
realization consistent with this standardWhile planning product realization determine
the following Quality objectives and requirements for the
product the need for
processes,documentation,resources and facilities specific to the product.
Required verification, validation, monitoring, inspection and test activities specific to the product and acceptance criteria.
Records.
7.2 Customer related process7.2.1 Determination of
requirements related to the product.
Product requirements specified by the customer including delivery and post delivery activities.
Requirements not specified but necessary for intended or specified use.
Obligations related to product, including regulatory and legal requirements.
Any additional requirements determined by the organization.
7.2.2 Review of Product requirementsReview identified requirements
and ensure before commitment to supply product that; product requirements are defined. Difference between tender and contract are
resolved. Organization has ability to meet the
requirements. In case of no documented customer
requirements, they shall be confirmed by the organization before acceptance.
In case of any changes concerned personnel and documents are up dated.
7.2.3 Customer communicationIdentify and implement
arrangements for communication with customers relating to:
product information inquiries contract and order
handling including amendments. Customer feedback including
complaints.
7.3 Design & development 7.3.1 Design & development
planning 7.3.2 Design & development input 7.3.3 Design & development
output 7.3.4 Design & development
review 7.3.5 Design & development
verification 7.3.6 Design & development
validation 7.3.7 Control of changes.
7.3.1 Design & development planning
Plan & control D&D of the productPlanning to include: D&D stages required review ,verification and
validation activities responsibilities and authorities for D&D.Interfaces between groups must be
managed.Planning to be updated as the D &D
progresses.
7.3.2 Design & development input
Define & document product requirements including
Functional and performance requirements.
Applicable regulatory and legal requirements.
Information from previous similar designs.
Any other essential requirements.Review input for adequacyReview for adequacy and resolve any
ambiguous,incomplete or conflicting requirements.
7.3.3 Design & development outputDocument D & D output allowing
verification.Provide information for production or
operations. D & D outputs shall
meet the input requirements Provide appropriate information for
purchasing, production and for service provision,
Contain or reference product acceptance criteria.
Specify the characteristics of the product that are essential for its safe and proper use.
7.3.4 Design & development review
At suitable stages review D &D to; evaluate the ability to fulfil
requirements. Identify problems and propose
follow-up.Involve all functions concerned.Record the results and follow up
actions.
7.3.5 Design & development verification Verify D & D to ensure that out put
meets the input requirements. Record the results of verification
and subsequent follow up actions.
7.3.6 Design & development validation Perform D & D validation to confirm that
product is capable of meeting the requirements for intended use.
Whenever applicable to be done prior to delivery.
Results of validation and follow up actions must be recorded.
7.3.7 Control of Design and Development changes Design and development changes
shall be identified and records maintained
Before implementation changes would be reviewed, verified, and validated.
Evaluation of the effect of the changes.
Record results of review of changes and follow up actions.
7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased
product.
7.4.1 Purchasing Process Control purchasing process to ensure that
purchased product meets requirements. Type & extent of control . Select suppliers based on their ability to
supply conforming product. Define criteria for selection and periodic
evaluation of suppliers. Results of evaluation and follow up actions
must be recorded.
7.4.2 Purchasing InformationPurchasing information shall describe Requirements for approval of product
.procedure, processes,equipment and personnel.
Requirements for qualification of personnel.
Quality management system requirements.
Ensure adequacy of specified purchase requirements prior to communication to supplier.
7.4.3 Verification of purchased product Identify and implement activities
needed to verify purchased product.
Where organization or its customer purpose verification at supplier premises,organization must specify in purchasing information:.
7.5 Production & service operations 7.5.1 Control of production and
service provision 7.5.2 Validation of processes 7.5.3 Identification &
Traceability 7.5.4 Customer property 7.5.5 Preservation of product.
7.5.1 Control of Production and service provisionControlled conditions for production &
services operations through: Availability of information specifying product
characteristics. Work instructions available where necessary. Use of suitable equipment. Availability & use of measuring and monitoring
devices. Implementation of monitoring and
measurements activities. Implementation of release,delivery and post
delivery activities.
7.5.2 Validation of Processes for Production and Service Provision
Shall validate process when… defined criteria for review and
approval approval of equipment and
qualification of personnel use of defined methods &
procedure requirements for record re-validation
7.5.3 Identification and tracebility Where appropriate identify product
through all stages of operations. Identify status with respect to
measurement & monitoring requirements.
Where traceability is required control & record unique identification of product.
7.5.4 Customer property Care for customer’s property being
under organization’s control or being used by organization.
Identification,verification,protection & maintenance of customer property provided for use or incorporation.
Any customer property that is lost,damaged or found un suitable must be recorded & reported to customer and record maintained.
7.5.5 Preservation of product Preserve conformity of product
during internal processing and final delivery to intended destination.
Include identification, handling, packaging, storage and protection.
This applies to constituent parts of product.
7.6 Control of monitoring & measuring devices
Shall establish process Calibrate & adjust measuring and monitoring
devices at specified intervals as prior to use. Traceability to international or national
standards.Where no such standard exist record the basis.
Safeguard MMD from adjustments invalidating calibration.
Protect MMD from damage or deterioration during handling,maintenance or storage.
Record results of calibration Assess validity of previous results when devices
found to be out of calibration.
7.6 (Significant addition or Modifications).The following specific requirements have been
omitted from the ISO 9001-1994 standard. “Documented Procedures” – omitted “measurement uncertainty is known” –
replaced with “measurement capability is consistent with the measuring requirements”
“test software” replaced with “validated prior to use”
“comparative references” – omitted “technical data.. Made available.. To
customer” omitted
“prescribed intervals” – replaced with “periodically or prior to use”
“define the process employed for the calibration…. Unsatisfactory” replaced with “ the basis used for calibration shall be recovered”
“identify… with a suitable indicator or approved identification record to show the calibration status” omitted.
“Ensure environmental conditions are suitable..” now covered by devices shall be used and controlled to ensure that measurement capability is consistent with the measuring requirements.”
8 Measurement,analysis and improvement 8.1 General 8.2 Monitoring & measurement 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring & measurement of
processes 8.2.4 Measurement and monitoring of
product
8.3 Control of non-conformity 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 preventive action
8.1 General
Plan & implement measurement and monitoring activities needed to assure
Conformance of the product Conformance to the quality
management system. Continual Improvement
8.2 Monitoring and Measurement
8.2.1 Customer satisfaction Organization shall monitor
information on customer satisfaction and /or dissatisfaction.
The methodologies for obtaining and utilizing such information must be determined.
8.2.2 Internal auditConduct periodic internal audit to
determine if QMS: Conforms to the requirements of the
standard. Has been effectively implemented &
maintained . Plan the audit program considering: Status and importance of the activity Results of previous audits
8.2.2 Internal auditAuditors shall not audit their own work The documented procedure must
cover: Responsibilities & authorities for
conducting audits Ensuring independence Recording results and reporting to
management Timely corrective actions. Follow up to verify & report
implementation of verification results.
8.2.3 Measurement and monitoring of processes Apply suitable methods for
measurement and monitoring of those realization processes necessary to meet customer’s requirements.
When planned results are not achieved
8.2.4 Measurement and monitoring of product Measure & monitor product
characteristics at appropriate stages. Evidence of conformity with the
acceptance criteria Records must indicate the authority
responsible for release of product. Release or delivery must not proceed
until all the specified activities have been completed unless otherwise approved by the customer.
8.3 Control of non conformity product Documented procedures for control non
conforming product to prevent unintended use or delivery.
The organization shall deal with non conforming product….
Taking action to eliminate the detected . Authorize under concession Preclude the original intended use Records of concession shall be maintained. Re verification Non conformity detected after delivery
8.4 Analysis of dataCollect & analyze data determine
suitability and effectiveness of QMS and to identify improvements that can be made.
Analyze data provide info on: Customer satisfaction and conformance to product requirement. Characteristics of product & process
and their trends suppliers
8.5 Improvement8.5.1 Continual Improvement Facilitate continual improvement using:
quality policy objectives audit results analysis of data corrective actions preventive actions. Management review
8.5.2 Corrective action
Action appropriate to the impact of problem.Documented procedures shall define requirements
for: Reviewing non-conformities determine the causes evaluating the need for corrective action determine corrective action needed and
implemented. Recording results of action Reviewing corrective action taken
8.5.3 Preventive actionOrganization must identify preventive action to
eliminate the causes of potential non conformances to prevent occurrences.
Actions appropriate to the impact of potential problem.
Documented procedures must define the requirements for
Determining potential nonconformaties and their causes
Evaluating the need for action to prevent occurrence of nonconformaties
Determining and ensuring implementation of preventive action needed.
Recording results of action taken. Reviewing preventive action taken.
QUALITY MANAGEMENT PRINCIPLES
PRINCIPLE 1 - CUSTOMER-FOCUSED ORGANISATION
Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
PRINCIPLE 2 - LEADERSHIP
Leaders establish unity of purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives.
QUALITY MANAGEMENT PRINCIPLES
PRINCIPLE 3 - INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit.
PRINCIPLE 4 - PROCESS APPROACH
A desired result is achieved more efficiently when related resources and activities are managed as a process
QUALITY MANAGEMENT PRINCIPLES
PRINCIPLE 5 - SYSTEM APPROACH TO MANAGEMENT
Identify, understanding and managing a system of interrelated processes for a given objective improves the organization's effectiveness and efficiency
PRINCIPLE 6 - CONTINUAL IMPROVEMENT
Continual improvement should be a permanent objective of the organisation
QUALITY MANAGEMENT PRINCIPLES
PRINCIPLE 7 - FACTUAL APPROACH TO DECISION
MAKING
Effective decisions are based on the analysis of data and information
PRINCIPLE 8 - MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value
SECTION # 5
Internal Audit Cycle
The Audit Assign the auditors to their area Sample the system Collect objective evidence of
system effectiveness Compare findings from checklist
with requirements decide compliance or
noncompliance Audit team daily meeting
Reasons for conducting Audits To examine a Quality Management
System for improvements. To ensure ISO 9000 requirements
are being complied with. To determine compliance or non-
compliance To meet regulatory requirements
Auditing Procedure The method for planning, initiating
and conducting audits and follow up activities including corrective actions
The rules for deciding the criticality of noncompliance
Auditing Procedure The format and distribution of
audit reports, noncompliance reports, checklists or other forms required for reporting
Records, storage and retention
PHASES OF AN AUDIT
PLANNING- Information Gathering- Annual Schedule- Estimate Resource
- Findings- Required Actions- Verify effectiveness
PERFORMANCE- Opening- Assess- Review Finding- Closing Meeting
PREPARATION
- Review Documents- Checklist- Agenda
REPORT &FOLLOW-UP
QUALIFIEDEXPERIENCED
SECTION 5-1
Planning
Initial Planning Decide who shall carry out the
audit Identify the relevant quality
specification or requirements Plan the date/time Gather information
Detailed Planning
Prepare program - send copy to auditee
Decide team composition Arrange team briefing Team prepare checklists
Detailed Planning
Notify auditee of arrangements / requirements
Duration of audit Composition of audit team Facilities for review etc.
Planning
The audit team The Team Leader if possible should
have the appropriate knowledge and experience of the industry and technology involved.
The Lead Auditor shall be adequately trained and have the ability to organize and lead the audit team.
Planning The auditor team members, shall
be trained in auditing techniques and have knowledge of the industry and technology involved
Auditors may be selected on the basis of their specialist discipline or expertise.(e.g., Design, Production, Computer Systems, etc.)
Planning The audit Team must be supplied
with copies of : The specification Copies of any documents they may
have to complete (e.g non-compliance, reports, checklists,etc)
Planning Team Size and Audit duration will
depend upon The size and complexity of the
department’s operation The standard/specification to be
appliedNote: A small dept. may take half
day whereas a larger one may take a two days or more
Planning Audit Team briefingIt is good management to arrange
for a meeting of the team, prior to the audit, to brief them on the requirements.
The briefing should cover: the program allocation of individual audit areas audit policies and practices
AUDIT PLANNING AUDIT PLANNING
Team Leader Candidates should be selected from qualifiedauditors with auditing experience.
Candidates should have a demonstrated ability tocommunicate effectively both orally and in writing.
Responsibilities
Make final decisions
Assist with selection of auditors
Represent audit team with management/ submit audit report
Direct follow-up activities
EXAMPLE OF AN AUDIT PLANEXAMPLE OF AN AUDIT PLAN
AUDIT PLAN
Procedure/Department
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
AUDIT KEYP - PLANNEDP/D - PLANNED & DONEU - UNSCHEDULED AUDIT PERFORMEDF - FOLLOW-UP AUDIT PLANNEDF/D - FOLLOW-UP COMPLETED
AUDIT ITINERARYAUDIT ITINERARYTime Team A (PM) Team B (WL)09:00-09:15 Opening Meeting09:15-12:00 Sales Department Engineering Department
- Contract Review - Document & Data control- Customer Complaint - Product Design & Development- Sample Control - Control of Production Fixture & ToolsPMC Department - Control of Inspection, Measuring- Production Planning & Text Equipment- Material Planning
12:00-13:)0 Lunch13:00-13:30 Auditor’s Meeting13:30-16:45 Store Production
- Material Store - Process Control- Finished Store - In-process InspectionQuality Department - Control of Non-conforming Products- Incoming Inspection & Testing Personnel Department- Final Inspection & Testing - Training- Corrective & Preventive General Manager Action - Internal Audit
- Management Review16:45-17:30 Auditors’ Meeting17:30-18:00 Closing Meeting
SECTION 5-2
Preparation
AUDITEE AUDITOR
Non-conformance Statements
Audit objectives Audit Schedule Notification of Audit
Selection of Audit Team Prepare Checklist Audit Plan
Audit team Auditee
Audit team
CAR (s) / Audit Report CAR Status Log
Team Leader
Team Leader QMR
Planning
Preparation
Conduct Audit
Complete Audit /Discuss Findings
Audit Report Back and Recording
Follow - up
Close - out
-investigate cause of nonconformance-return completed CAR
-implement necessary corrective / preventive action and monitor for effectiveness.
AUDIT PREPARATIONAUDIT PREPARATION
Selection of Audit Team
Auditor Independence
Trained Auditor
Auditor credibility
AUDIT PREPARATIONAUDIT PREPARATION
Checklists- Preparation Reflects objective and scope of the audit
Sources of information for checklists
- previous internal Audit Report / CAR (s)
- previous checklist
- auditee Quality Documents
- known quality problems
AUDIT PREPARATIONAUDIT PREPARATION
Checklist - Preparation
WHAT the auditor wants to look for
WHOM the auditor wants to speak to
WHAT the auditor wants to speak about
AUDIT PREPARATIONAUDIT PREPARATION
Checklist Questions
Based on Quality Documentation used by the Dept.to be Audited.
From the documentation Identify all thekey things involved / to be done
Record the key things on the checklistas things to be checked.
Include references to all forms and otherdocumentation, i.e. other procedures / W.I.
IDENTIFYING PROCEDURES TO AUDITIDENTIFYING PROCEDURES TO AUDIT
ISO Elements
Area
Stores x x x x o x x x x x x
Product line 1 x x x x x x x x x x x x x
Q.A.
Legend: X = Direct Relationship
O = In-direct Relationship
DocRef
Requirement Y N Comments
4.1
4.2
Doc# Purchasing - AB-Q501 / Rev: 1Stock items established via monthlymeeting - Comm. / Purch MgrNon stock via PR from dept. sent toComm. MgrCap-ex items approved by MD.
4.4
4.3
4.6
4.8
4.7
ASL held by commercial deptR.M. specifications in LabSupplier approved via Head OfficeSupplier approved Local:- satisfactory supply- on-site assessment (TP 453)- product samples- other users experiencePurchase orders approved by Comm. Mgr.
P.O. contain: - description of goods/services - type,class,grade, quality - drawings specificationsRevisions: New P.O. released identified asrevised
AUDIT PREPARATION
Study Documents
Agenda Checklist
Team Briefing
Compliance or Documentation Review An audit to determine the extent to
which the documented system meets the requirements of a specified standard.
Normally carried out in advance of an audit and may be referred to as a desktop audit
Conformance or Compliance Audit
An audit conducted to determine that the quality system is being implemented
Checklists
Used by the assessor as an aide memoire
Ensure that all elements of a specification are addressed
Are compiled from the results of a detailed study of the procedure/specification
Ensure that all relevant requirements contained in the specification are covered
Checklists Assist with obtaining proof that the
requirements contained in the specification are being implemented
Used to reference each question to the relevant clauses of the specification
Are an invaluable aid when writing the audit report.
Space should be left on the checklist so that answers to the questions can be noted for later use.
ChecklistsChecklists will be expected to ensure
that :- Each requirement of the specification to
which the auditee’s quality system has been documented is examined, to ensure that the system covers every element/requirement and that each one is effective.
Procedures and work instructions are reviewed for completeness, adequacy and issue levels against a master list.
Checklists Evidence of the implementation of
procedures and instructions in the work areas being audited. The procedures and instructions are to the required issue and their distribution controlled.
Corrective actions which have been undertaken to clear any previous noncompliances, are to be followed up.
To provide guidelines for the auditor
To ensure every part of the audit is completed
To reinforce objectives and scope
PURPOSE OF THE CHECKLISTPURPOSE OF THE CHECKLIST
Consider: the processes taking place relevant procedures documents in use records requirements of ISO 9001
PREPARING A CHECKLISTPREPARING A CHECKLIST
AUDIT CHECKLIST
Job Ref : NDB Procedure: QP008 / Issue B / Rev.1 Auditor : P.C. Chan
Sheet No. 1 of 4
Item No.
Requirement Comments/Remarks
Activity ComplianceYes/No
Receiving CheckFor small packet, By Foreman - Visual check- Identified & Marked off against the P.O.- Until required (what does it means?), unpacked/ inspected / put into storeFor Plant / Equipment, By Foreman- Quantity check against Engineers order- Damage check- For specialised equipment, need to sign DN, may be by Chargehand- Equipment Acceptance Cert send to Contract EngineerBy Foreman for all items:- Check DN about Order No., Quantity or Weight Supplier’s name & her Order No. Description
4.01
4.02
4.01
AUDIT CHECKLIST
Job Ref. : NDB Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Sheet No. 2 of 4
Item No.
Requirement Comments/Remarks
Activity ComplianceYes/No
- Check DN against PO- Send test Cert to site eng.If all Ok, sign Material Received Copy, send to Engg:Dept with D.N.
IF Non-conformity found
Inform Contract EngineerIndicated with Red Label with defect’s detail, separately locatedDisposition by Site EngineerFill Non-conforming item input sheet (Distribution required?)If found after stored, remedial work.Record on either one- Non-Conforming Item Report Sheet- Non-Conforming Workmanship Report Sheet
4.014.06
4.11
4.09
AUDIT CHECKLIST
Item No.
Requirement Comments/Remarks
Activity ComplianceYes/No
Storage / Issuance
Site/Contract Engg ensure suitable stores facilitiesGoods Received Register fill by Foreman- Date received- Supplier- Item description- Quantity record- NDB order No.- Remark of shortage / defectsEstablish item location with identification.Location of major item to be agreed by site Engg.Label of acceptable item used and with necessary description.Who’s responsibility
4.034.04
4.05
Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Job Ref. : NDB Sheet No. 3 of 4
AUDIT CHECKLIST
Item No.
Requirement Activity ComplianceYes/No
Comments/Remarks
Item issued by Foreman or Site Engg with Material issued Register- Item description- Quantity- Stock balance- Recipient- Issue date- Foreman or Engg SignedHow about Plant / Equipments? (Not mentioned in QP)
Stores Foreman conduct regular check on stock item for - Condition- Quantity Vs Balance of Material Issued RegisterInform Engg to Re-order.
4.07
4.08
Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan
Job Ref. : NDB Sheet No. 4 of 4
SECTION 5-3
AUDIT Conduction
AUDITEE AUDITOR
Non-conformance Statements
Audit objectivesAudit ScheduleNotification of AuditSelection of Audit TeamPrepare ChecklistAudit PlanAudit teamAuditeeAudit teamCAR (s) / Audit Report
CAR Status LogTeam LeaderTeam LeaderQMR
Planning
Preparation
Conduct Audit
Complete Audit /Discuss Findings
Audit Report Back and Recording
Follow - up
Close - out
-investigate cause of non- conformance
-return complete CAR
-implement necessary corrective / preventive action and monitor foreffectiveness.
The Audit
REMEMBER : THE AUDIT TEAM IS ATTEMPTING TO APPROVE THE SYSTEM BASED UPON AN UNBIASED ASSESSMENT.
IT IS NOT ATTEMPTING TO FAIL IT!
The Audit
ESTABLISHING THE FACTS AND FINDING THE PROOF WITHOUT NONCOMPLIANCES THE EVIDENCE MAY BE THE EFFECT AND NOT THE CAUSE
Sampling
Scope Duration of
Audit Requirements of
the standard Complexity of
the process
Considerations:
• Previous Problems• Important aspects• Auditor skills /
knowledge• Sample size and its
significance
Auditor
Auditee
PERSONAL CONDUCT
positive, professional, constructive approach
co-operative, open, honest
Support from management Trained auditors Independence of audit
function Timely access to facilities,
documents, personnel Access to all levels of
management Defined audit procedures
FUNDAMENTAL REQUIREMENTS FOR EFFECTIVE AUDITINGFUNDAMENTAL REQUIREMENTS FOR EFFECTIVE AUDITING
The Opening Meeting Punctuality - arrive on time The meeting should be brief and to the
point General introductions by the audit team
and management A review of the program
good communication
co-operation openness
THE OPENING MEETING
NECESSARY FOR:
People Processes Equipment / tools /
materials Documentation
AN AUDITOR "VERIFIES" BY OBTAINING OBJECTIVE EVIDENCE
Record Past implementation
Examined / Observed Current implementation
Method Stated Staff knowledge &
understanding
OBJECTIVE EVIDENCEOBJECTIVE EVIDENCE
Objective Evidence
Try to establish :- That authorised documents are in
use That superseded drawings have
been removed That good housekeeping is practised That facilities are adequate That supervision is adequate
IAC S7 . 5 . 1
Objective Evidence
That orderly records are kept That staff are adequately trained Assess attitude of management
and staff towards the quality system
Well prepared checklists will assist when answering these questions
LAC S7 . 6 . 1
Objective EvidenceObjective Evidence
Establish the fact and find the proof
With nonconformities the evidence may be the effect and not the cause
meet the area representative first
always talk to those performing the task
explain the purpose of the visit
be calm, polite, reassuring never talk down speak clearly and carefully
THE AUDITOR'S APPROACH
examine objective evidence ask open-ended questions refer to checklists make notes consider impact on other
activities examine physical
conditions
CONDUCTING THE AUDIT
ASK
LOOK
LISTEN
How Whe
re Whe
n Wha
t Why Who
QUESTIONING TECHNIQUES
6 important words
Audit Techniques
Ask Questions Examine Objective
Evidence Observe Activities Listen to Reactions Record Findings
The Auditors Six FriendsThe Auditors Six Friends
When asking questions…..Who ?
What ?Where ?
When ? Why ?
How ? and the seventh Ok Show Me ?
Question Technique
YES / NO questions Often elicit dead end answers - you gain
nothing - Only useful as a leader questionHow - What - Why - When - Where - Who ? Direct questions - will achieve more detailed
answers.Explanation questions Useful for comparing interfaces
Questioning Techniques
Keeps conversation going Repeat last word or phrase - say
something niceAvoid double questions (2 questions
in 1) Only one answer is likely to result
IAC S7 . 4 . 1
Audit Techniques Forward Trace - An audit which
follows the natural flow of a product or service process
Background Trace - An audit which traces records back through the system
Observations Notes made by an auditor during
assessment may lead to noncompliances being raised or to provide information for the audit report.
Notes provide Objective Evidence back up
Observations
Observations may be obtained through any of the following methods:
Seeking objective evidence that the system is functioning as prescribed.
Samples taken of the system will allow the auditor to obtain the required evidence
Observations Always establish objective evidence
when an apparent noncompliance is found remember the occurrence discovered may be the effect and not the cause.
Where processes are involved the audit may examine the process controls and records to establish conformance with the specification
Both positive and negative observations are recorded
Observations Throughout the entire audit the
evidence collected in the form of OBSERVATIONS is to be recorded on the auditors checklists.
This evidence is then to be examined to determine if there are any noncompliances which need to be reported.
ObservationsObservations
A statement of fact made during an audit and substantiated by objective evidence
Observations are recorded on the auditors checklist throughout the audit
Both positive and negative observations are recorded
Negative observations may lead to noncompliances being raised where evidence exists, indicating a deviation from the standard
Observations may be included in the audit report to draw management’s attention to improvement opportunities
Definition
Noncompliance Reporting
Complete audit findings Must be factual Must be understandable and traceable Raise noncompliances on completion of an
audit The auditee is requested to sign signifying an
understanding and acceptance of the noncompliance.
MAJOR total breakdown of a procedure, work
instruction or operation of the Quality System total absence of a procedure required by
Standard number of minor lapses indicating a total
breakdown of system immediate hazard to the quality of the product
or service MINOR
· a single observed lapse in a procedure, work instruction or operation of the Quality System
CLASSIFICATION OF CARsCLASSIFICATION OF CARs
NoncomplianceNoncompliance
Nonfulfilment of a specified requirement
It is important to establish the ownership of each noncompliance
Nonconpliances are owned by the auditee not the auditor
It is important to establish who has the authority to sanction the corrective action resulting from noncompliances
Definition
NoncomplianceNoncompliance
The opening meeting should establish the authority and the reporting routes
The auditee should have an internal system for dealing with corrective actions
The noncompliance report is the method used to indicate the devations to the system
Noncomformities arise from observations made during the audit
Noncompliance Reporting
What is the Problem ?describe clearly, concisely and
factually Why is it a noncompliance ?
i.e. against what requirement Where did it occur ?
i.e. which department or activity
Who ? - avoid apportioning blame(i.e. naming individuals)
Noncompliance Reporting
Complete audit findings Must be factual Must be understandable and traceable Raise noncompliances on completion of an
audit The auditee is requested to sign, signifying
an understanding and acceptance of the noncompliance
Noncompliance ReportingNoncompliance Reporting
Information to be recorded Identification /Serial number The nature of the noncompliance Where,
What,Why Reference numbers of Documents/ Materials etc. Auditee/ contact Clause of the standard or specification applicable Category of noncompliance (if applicable) Agreed corrective action and timescale Follow up action See Noncompliance Report Form
the audited process or procedure is being not conducted or completed as it should
NONCONFORMANCENONCONFORMANCE
comply with the Standard implement quality manual,
procedures or other documented requirements
implement a code of practice, regulation or contract
_______________
no requirement = no nonconformance
A NONCONFORMANCE MAY BE A FAILURE TO:A NONCONFORMANCE MAY BE A FAILURE TO:
include: overview of finding description of
nonconformance example of objective
evidence summary of requirement
FINDING STATEMENTFINDING STATEMENT
EXAMPLE OF NON-COMPLIANCE STATEMENTEXAMPLE OF NON-COMPLIANCE STATEMENT
Standard: ISO 9001:2000
Procedure: QP6 Issue 2
Area: Purchasing Dept.
1. The procedure is not being implemented in full in
that not all purchase orders are being fully
completed. For example; Pos 1234 and 1235
do not contain prices or delivery dates.
2. All Purchase Orders must be completed in
accordance with Procedure QP6.
Used to: report nonconformances classify nonconformances record acceptance of
nonconformances record actions taken to correct
nonconformances record auditor acceptance of
corrective action implementation
CORRECTIVE ACTION REQUESTS (CARs)CORRECTIVE ACTION REQUESTS (CARs)
CORRECTIVE ACTION REQUEST (CAR) FORMCORRECTIVE ACTION REQUEST (CAR) FORM
CORRECTIVE ACTION REQUEST
AUDIT NO.:
AUDITOR: CAR NO.: OF
DEPT. REPRESENTATIVE AUDIT DATE:
PROCEDURE NO: AREA/DEPT/FUNCTIONISSUE:
DETAILS OF NONCONFORMANCE:
SIGNED: SIGNED:AUDITOR DEPT. REP
CORRECTIVE ACTIONS:
SIGNED:DEPT. REP.:
RE-AUDIT RESULTS:
SIGNED:AUDITOR: DATE:
COMPLETING THE AUDIT
- audit team meeting to discuss all findings
Review Audit Findings:
- team leader to make final decisions- all findings to be supported by objective evidence
Write non-compliance statements- non-conformance statements to be recorded on the CAR
Report-back meeting
NON-CONFORMANCENON-CONFORMANCE A failure to comply with a requirement. The fault
may be caused by the failure of the system to comply orfailure to implement the system itself._______________________________________
NON-CONFORMANCE STATEMENTSNON-CONFORMANCE STATEMENTS
Non-conformance statements are statements that explicitly express the identified non-conformityalong with the supporting evidence. They generallyinclude the following:
The Deficiency The Objective Evidence Details of the Deficiency
Where What
Who
NON-CONFORMANCE STATEMENTSIn the machine shop, a diameter on drawing D330 issue A
had been changed by the Forman. There was no evidencethat the change had been authorized by the designdepartment.
The operator(s) in the Machine Shop were supposed to
sign off each operation on the route card. On the routecard for batch number 134 there were no signature(s)against completing machining operations 1 and 4.
NON-CONFORMANCE STATEMENTS
L/C 341-6787 for a customer under credit grade of # 8 for the amount of USD 400,000 FOB, there was no evidence of any insurance provided.The procedure requires that for the issue of L/C’s to customers under credit grade 7-10 over USD 325,000 under FOB and C&F terms evidence of insurance is required.
For L/C 1234567 issued by a local bank for USD 65,000 no verification was done by CSC.
According to the procedure all L/C issued by local banks for values over USD 50,000 from to be verified by CSC before being sent toTPC for scanning and advising.
NON-CONFORMANCE STATEMENTS
NON-CONFORMANCE STATEMENTS
Customer complaint from the ABC company had not been followed up and no action had been carried out whatsoever.
According to the procedure QP 13 paragraph 4.6 all customer complaints are to be followed up in the Quality Improvement Committee.
LAC 09.08 / 05
EXAMPLE OF CORRECTIVE ACTION REQUEST
Company:
Job No:
Assessor:
Company Representative:
Procedure No:Issue:
Details of Non-Conformance:
Signed:CompanyRepresentative:
Corrective Action taken to prevent recurrence:
Signed:Company Representative
Acceptance of Corrective Action/Comments
Visit No:
Assessment Date:
Area/Dept/Function:
CAR No.: of
ISO 9001/2/3/REFClause
Major CARProposedClose out date:
Signed:Assessor:
Date:
:
not essential
effective corrective action more important
audits should be positive and constructive
purpose is system improvement
CLASSIFICATIONFIRST PARTY AUDITSCLASSIFICATIONFIRST PARTY AUDITS
Closing meeting
Thank management Explain that sample taken has
determined conclusion reached Present summary report
Quantify noncompliance Conclusion Recommendations
Closing Meeting Each team member to present
noncompliance details Invite questions - for clarification only Agree distribution of final report Make statement of confidentiality
be side-tracked be led or misled get "bogged down" let the auditee dictate
the pace make assumptions or
presumptions
CONTROL THE AUDIT
DO NOT
Be prepared Be punctual Insist on auditee answering
questions As little talking as possible Avoid misunderstandings Keep questions clear and
concise Polite and calm
CONTROL THE AUDITDO
good points which may benefit other areas of organisation
areas of concern deficiencies given the “benefit
of the doubt” suggestions for action
OBSERVATIONSOBSERVATIONS
aggressive auditees timid auditees missing people missing documents pre-prepared samples (choose your
own !)
BE AWARE OF
SECTION 5-4
Audit Follow Up & Close Out
AUDITEE AUDITOR
Non-conformance Statements
Audit objectivesAudit ScheduleNotification of AuditSelection of Audit TeamPrepare ChecklistAudit PlanAudit teamAuditeeAudit teamCAR (s) / Audit Report
CAR Status LogTeam LeaderTeam LeaderQMR
Planning
Preparation
Conduct Audit
Complete Audit /Discuss Findings
Audit Report Back and Recording
Follow - up
Close - out
-investigate cause of non- conformance
-return complete CAR
-implement necessary corrective / preventive action and monitor foreffectiveness.
Hold an Opening Meeting
Conduct the audit
Analyse the results
Report the findings
AUDIT PROCESSAUDIT PROCESS
Action taken to eliminate the causes of an existing noncompliance, defect or other undesirable situation in order to prevent recurrence
CORRECTIVE ACTIONCORRECTIVE ACTION
Action by management of area audited:· take immediate remedial action· analyse effects on product· identify root cause· identify other areas where “problem”
may exist· develop effective actions to prevent
recurrence· implement and monitor actions
CORRECTIVE ACTION PLANCORRECTIVE ACTION PLAN
RESPONSIBILITY OF MANAGERS RECEIVING A CAR
1. Investigate the problem
2. Determine the cause
3. Decide on appropriate corrective action and target date for implementation.
4. Send the completed form to the CAR administrator
5. Implement corrective action
C.A.R. FLOWC.A.R. FLOW
C.A.R. Raised
Signed & Issued Accepted
Investigate & Analyze
Implemented
Corrective Action DocumentedReviewed
Reviewed
Reject Accept
Closed Out
RecordRecord
The Report should:· describe audit scope· identify auditors· identify departmental
representatives· state overall findings· describe deficiencies,
observations· provide objective evidence· be easy to read and
understand
AUDIT REPORTAUDIT REPORT
INTERNAL AUDIT REPORTINTERNAL AUDIT REPORT
INTERNAL QUALITY SYSTM AUDIT REPORT
AUDITOR’S NAME AUDIT REPORT NUMBER
DEPARTMENTAL REPRESENTATIVE DATE OF AUDIT
QUALITY FUNCTION or PREVIOUS AUDIT DATE AND RESULTSPROCEDURES(S) AUDITED
SUMMARY AUDIT:
SIGNED: _______________________(AUDITOR) DATE: _______________________
exists is complete operates correctly is effective
AIMS OF THE AUDIT
To verify that the quality system:
REPORTS and RECORDS Complete and sign all CAR.
Prepare Audit Report.
Prepare for the report-back meeting
explain, support and justify findings
obtain agreement on CARs
ensure good points are mentioned
state overall degree of compliance
reinforce objectives and scope
PRESENTING THE FINDINGSPRESENTING THE FINDINGS
REPORT BACK MEETING Have Your Reports Ready
Discuss Positive As Well As Negative Aspects
Make Sure Reports Are Agreed By All Parties
REPORT-BACK MEETING“CHECKLIST”
To be chaired by audit team leader.
Repeat purpose and scope of audit.
Thank auditee
Comment on good points.
State overall compliance
Read non-compliance statements.
Do not argue.
Arrange follow-up (to close out corrective actions).
Take minutes of meeting for any follow up.
Close meeting.
Checklist
Procedure QP-10
F O L L O W UPSubsequent follow up should review:
- audit file
c- corrective action file
Review should examine actions required and whether completed andwhether the actions have been effectiveto prevent recurrence.
Action by Quality Manager:· approve proposed corrective
actions· monitor progress in completing
corrective actions· arrange follow-up to verify
effectiveness· escalate to higher management
if necessary
CORRECTIVE ACTION PLANCORRECTIVE ACTION PLAN
shows status of:
· CARs
· follow-up action
· ‘close-out’
· CARs from second and third
party audits
CAR STATUS LOGCAR STATUS LOG
CAR STATUS LOG
CAR CAR DEFICIENCY AUDIT INITIALS DATE CORRECTIVE ACTION PROPOSED DATESERIAL ISSUED DATE OF REMINDER ACTION PREVENT FOLLOW- CARNO. TO AUDITOR SENT COMPLETION RECURRENCE UP DATE CLOSED
DATE
CORRECTIVE ACTION REQUEST (CAR) STATUS LOG
AUDIT FOLLOW-UPAUDIT FOLLOW-UP
audit objective evidence verify corrective action(s)
implemented ensure short and long term
effectiveness record details of follow-up
sign-off forms audit documents retained as
records
Why ??
FOLLOW-UP OF THE CORRECTIVE ACTION
WHY?
To ensure corrective action has prevented any recurrences
To determine whether corrective action has been effective?
CLOSE-OUT THE CAR? Each non-conformance is to be closed out
individually
> Ensure that the corrective action has addressed the root cause of the non- conformance
> Not treated the symptoms only but prevented recurrence of the non conformity.
> When the auditor is satisfied there is no further example of the non-conformance.
CLOSED-OUT
CAR
MANAGEMENT REVIEWMANAGEMENT REVIEW
internal audits reported
audit results analysed
status of corrective actions reported
preventive actions identified
INTERNAL AUDIT -THE SYSTEMManagement
Management Review
Follow-up/Close out
Audit Schedule
Corrective/Preventive Action
Conduct Audit
CAR Requests
SECTION 6
Auditor Desirable Characteristics
Management Style
“Tell” This approach is where the team leader
plans and makes the decisions up front and then gives clear instructions - directing the team the way he or she wants the task to proceed
This style may well be welcomed by the less experienced team members, but may not always receive approval from those more experienced who feel they have something to contribute.
Management Style
“Consult” The consult approach is where the team
leader takes time to talk to the team members first, listen to their ideas and evaluate their capabilities before making a decision.
This is probably the preferred approach, but if time is a constraint and the team ia not available then this approach may not be possible.
Management Style “Team” The team approach is when the team
leader acts more as a chairperson seeking concise opinions and allowing other team members to take an active role in the decision making process.
This approach is perhaps more useful when preparing for the final report. Giving the opportunity for the final report to be truly representative of the whole teams findings.
good listener open-minded diplomatic unbiased honest patient self-disciplined
SELECTING AUDITORSDESIRABLE TRAITSSELECTING AUDITORSDESIRABLE TRAITS
arrogant opinionated self-important lazy argumentative shy timid
SELECTING AUDITORSUNDESIRABLE TRAITSSELECTING AUDITORSUNDESIRABLE TRAITS
Auditor Characteristics
These include skills of being :
Diplomatic Patient Honest Fair minded Impartial Articulate Communicative Analytical
Helpful Co-operative Persistent Observant Ethical Professional
Code of Conduct To act in strictly trustworthy and
unbiased manner To disclose any relevant relationships Not accept inducements Not to disclose findings Not to act in any way prejudicial to the
organization In the event of an alleged breach co-
operate fully
stay within audit scope communicate audit
requirements collate objective evidence document CARs report audit findings verify effectiveness of
corrective actions retain and safeguard
documents
AUDITORS SHOULDAUDITORS SHOULD
prepare - know the subject material
learn about the auditee remain objective control the audit assist if there is a
misunderstanding listen obtain objective evidence compliment the auditee
WHAT AN AUDITOR SHOULD DOWHAT AN AUDITOR SHOULD DO
swear be sarcastic discuss/criticize company policies
personalities be negative criticise argue compare auditee with others
WHAT AN AUDITOR SHOULD NOT DOWHAT AN AUDITOR SHOULD NOT DO
introduce self and team ensure agenda is known and
understood keep to agenda keep to time keep control avoid arguments listen to others maintain records
GOOD PRACTICE AT MEETINGS
Thanks
ANIL KUMAR