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 2 Introduction 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 Industry DTI Accredit Certification Bodies Calibration & Test Houses Certify Companies / Organisations United Kingdom Accreditation Service UKAS EXAMPLES SHOWN FOR UK REGISTRATION
Section 3 Quality 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 System Documentation Quality Manual Quality System Procedures Work Instructions Forms
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, or Function, or Group of functions Understandable Useable Written for Written In an agreed format QUALITY SYSTEM PROCEDURES
PROCEDURE FORMAT PURPOSE SCOPE REFERENCES DEFINTIONS PROCEDURE/ METHODS ASSOCIATED DOCUMENTS 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 Standard ISO 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 4 Introduction 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.
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 Documents Documents 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 Review 5.6.1 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 Input Review 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 Infrastructure Identify ,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 processes Plan and develop processes for product realization consistent with this standard While 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 process 7.2.1 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 requirements Review 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 communication Identify 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 product Planning 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 adequacy Review for adequacy and resolve any ambiguous,incomplete or conflicting requirements.
7.3.3 Design & development output Document 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 Information Purchasing 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 provision Controlled 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 audit Conduct 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 audit Auditors 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 data Collect & 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
8.5.2 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 action Organization 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
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 applied Note: A small dept. may take half day whereas a larger one may take a two days or more
Planning Audit Team briefing It 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 Team Leader Candidates should be selected from qualified auditors with auditing experience. Candidates should have a demonstrated ability to communicate 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 PLAN AUDIT PLAN Procedure/ Department JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC AUDIT KEY P - PLANNED P/D - PLANNED & DONE U - UNSCHEDULED AUDIT PERFORMED F - FOLLOW-UP AUDIT PLANNED F/D - FOLLOW-UP COMPLETED
AUDIT ITINERARY Time Team A (PM) Team B (WL) 09:00-09:15 Opening Meeting 09:15-12:00 Sales Department Engineering Department - Contract Review - Document & Data control - Customer Complaint - Product Design & Development - Sample Control - Control of Production Fixture & Tools PMC Department - Control of Inspection, Measuring - Production Planning & Text Equipment - Material Planning 12:00-13:)0 Lunch 13:00-13:30 Auditor’s Meeting 13:30-16:45 Store Production - Material Store - Process Control - Finished Store - In-process Inspection Quality Department - Control of Non-conforming Products - Incoming Inspection & Testing Personnel Department - Final Inspection & Testing - Training - Corrective & Preventive General Manager Action - Internal Audit - Management Review 16:45-17:30 Auditors’ Meeting 17:30-18:00 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 PREPARATION Selection of Audit Team Auditor Independence Trained Auditor Auditor credibility
AUDIT 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 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 PREPARATION Checklist Questions Based on Quality Documentation used by the Dept.to be Audited. From the documentation Identify all the key things involved / to be done Record the key things on the checklist as things to be checked. Include references to all forms and other documentation, i.e. other procedures / W.I.
IDENTIFYING 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
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.
Checklists Checklists 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 CHECKLIST
Consider: the processes taking place relevant procedures documents in use records requirements of ISO 9001 PREPARING 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 Compliance Yes/No Receiving Check For small packet, By Foreman - Visual check - Identified & Marked off against the P.O. - Until required (what does it means?), unpacked/ inspected / put into store For 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 Engineer By 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 Compliance Yes/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 Engineer Indicated with Red Label with defect’s detail, separately located Disposition by Site Engineer Fill 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 4.01 4.06 4.11 4.09
AUDIT CHECKLIST Item No. Requirement Comments/ Remarks Activity Compliance Yes/No Storage / Issuance Site/Contract Engg ensure suitable stores facilities Goods Received Register fill by Foreman - Date received - Supplier - Item description - Quantity record - NDB order No. - Remark of shortage / defects Establish 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 4.03 4.04 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 Compliance Yes/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 Signed How about Plant / Equipments? (Not mentioned in QP) Stores Foreman conduct regular check on stock item for - Condition - Quantity Vs Balance of Material Issued Register Inform 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 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 non- conformance -return complete CAR -implement necessary corrective / preventive action and monitor for effectiveness.
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
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 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 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 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 Where When What Why Who QUESTIONING TECHNIQUES 6 important words
Audit Techniques Ask Questions Examine Objective Evidence Observe Activities Listen to Reactions Record Findings
The 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 question How - 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 nice Avoid 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.
Observations 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 CARs
Noncompliance 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
Noncompliance 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 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 NONCONFORMANCE
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:
include: overview of finding description of nonconformance example of objective evidence summary of requirement FINDING STATEMENT
EXAMPLE 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)
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-CONFORMANCE A failure to comply with a requirement. The fault may be caused by the failure of the system to comply or failure to implement the system itself . _______________________________________ NON-CONFORMANCE STATEMENTS Non-conformance statements are statements that explicitly express the identified non-conformity along with the supporting evidence. They generally include the following: The Deficiency The Objective Evidence Details of the Deficiency Where What Who
NON-CONFORMANCE STATEMENTS In the machine shop, a diameter on drawing D330 issue A had been changed by the Forman. There was no evidence that the change had been authorized by the design department. The operator(s) in the Machine Shop were supposed to sign off each operation on the route card. On the route card 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 to TPC 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: Company Representative: 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/REF Clause Major CAR Proposed Close out date: Signed: Assessor: Date: :
not essential effective corrective action more important audits should be positive and constructive purpose is system improvement CLASSIFICATION FIRST 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 AUDIT DO
good points which may benefit other areas of organisation areas of concern deficiencies given the “ benefit of the doubt ” suggestions for action OBSERVATIONS
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 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 non- conformance -return complete CAR -implement necessary corrective / preventive action and monitor for effectiveness.
Hold an Opening Meeting Conduct the audit Analyse the results Report the findings AUDIT PROCESS
Action taken to eliminate the causes of an existing noncompliance, defect or other undesirable situation in order to prevent recurrence CORRECTIVE 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 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. FLOW C.A.R. Raised Signed & Issued Accepted Investigate & Analyze Implemented Corrective Action Documented Reviewed Reviewed Reject Accept Closed Out Record Record
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 REPORT
INTERNAL 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 RESULTS PROCEDURES(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 FINDINGS
R EPORT BACK MEETING Have Your Reports Ready Discuss Positive As Well As Negative Aspects Make Sure Reports Are Agreed By All Parties
R EPORT-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 UP Subsequent follow up should review: - audit file c - corrective action file Review should examine actions required and whether completed and whether the actions have been effective to 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 PLAN
shows status of: CARs follow-up action ‘ close-out ’ CARs from second and third party audits CAR STATUS LOG
CAR STATUS LOG CAR CAR DEFICIENCY AUDIT INITIALS DATE CORRECTIVE ACTION PROPOSED DATE SERIAL ISSUED DATE OF REMINDER ACTION PREVENT FOLLOW- CAR NO. TO AUDITOR SENT COMPLETION RECURRENCE UP DATE CLOSED DATE CORRECTIVE ACTION REQUEST (CAR) STATUS LOG
AUDIT 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 REVIEW internal audits reported audit results analysed status of corrective actions reported preventive actions identified
INTERNAL AUDIT - THE SYSTEM Management 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.
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 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 DO
swear be sarcastic discuss/criticize company policies personalities be negative criticise argue compare auditee with others WHAT 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