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COURSE OBJECTIVE
Purpose of Audit Define Audit Terms Auditor Independence Audit Preparation Conducting An audit Reporting Follow up
Why Audit
Formal requirement of ISO 9001:2000 Standard To encourage continuous improvement To give managers feedback on their systems To help employees understand corporate goals and procedures To monitor progress on targets and objectives
What to Audit ?
Understanding of corporate policies and objectives Compliance to procedure and standards Effective control on documentation & standards Record preparation & filing Competence and training of staff to perform job effectively Commitment of managers and workers towards continuous improvement
How Often ?
All departments at least once a year More regular audits in areas where there are problems, new personnel or regular customer visits In response to customer complaints Include off-site locations like stores and marketing offices Right after an emergency or management change Before certification audits and/or customer visits
Who Audits ?
Auditors should be selected from all departments in the organisation Auditor selected for an audit should be independent from the function being audited Auditors should include personnel from both the top and middle management Auditors must be allocated time needed to study documents, perform the audit and report on findings Presentation skills are also important
Auditor Competence
Quality
Quality Specific knowledge and skills (7.3.3)
Types of Audits
Systems Audits - ISO 9000 Financial Audits Safety Audits Customer Audits Regulatory Audits - Factory Law, Labour Law & Environmental Law
In general there are three types of audits First Party Second Party Third Party Audits
Audits conducted against corporate policies, procedures and standards Schedule and frequency against audit programmes and/or special circumstances Auditors chosen from a cross section of departments
Audits against standards imposed by businesses onto their suppliers Supplier audits are very common in automotive, textile & food industry prompt delivery of zero defect product is vital
These audits typically look at enforcing fewer defects for products & services better response on customer service documentation on inspection & testing better storage & handling of product equipment maintenance & calibration
Performed by independent authorities These include certification bodies, inspection agencies and surveyors These audits are regulated by accreditation authorities and other associations like
United Kingdom Accreditation Services American Petroleum Institute American Society of Mechanical Engineers
Phases of an Internal Audit
AUDIT INITIATION
Phase I
Initiation
Quarterly or six month or annual
department wise frequency circulated to all staff will change based on results of audit and performance of departments
Audit basis ISO 9001, Company policy, etc.. Audit scope Extent and boundaries of audit Audit Objectives Compliance against ISO 9001, improvement of current system, closing out previous NCs
The status and importance of the activity The results of the previous audits (internal & external) Corrective Actions Changes to systems elements Introduction to new methods and technology Organizational and personnel changes The risk to quality if audit frequency is reduced Availability of audit personnel
The audit objectives and criteria The audit scope including processes to be audited The dates and places where the on-site audit activities are to be conducted The expected time and duration for the on-site activities including safety/security requirements
Persons to be interviewed
Competency of auditors
AUDIT PLANNING
Inform auditor, auditee Make arrangements - guide, safety Examine documents Prepare checklists
What is a Checklist?
A structured list of points to evaluate Identifies and communicates the scope of an audit
An auditors tool to gather evidence and provide an audit trail Guides the course and controls the pace of an audit
Keeps audit relevant to objective Provides evidence of planning Memoir Assists note taking Reduces risk to bias Manages time Assists in the preparation of audit report
Types of Checklists
Standard Ready formatted Facilitates consistency across different area's) Uniform questions Can be inflexible Not suited to all types of audit
Customised Constructed as and when needed Usually specific to a particular audit Assists preparation by client organisation Demonstrates professional approach by Audit team
Format of checklist
Product Types
AUDIT EXECUTION
Opening meeting
Interview personnel Examine documents Observe processes Examine materials and equipment
Introductions, if applicable
Ensure who you are auditing and their organizational responsibilities Explain the importance of the audit Ask for the auditees help in achieving the objectives of the audit Ask permission before disturbing work in progress Obtain auditees acknowledgement on any NCs you are recording Ask the auditee if they have any points about the audit or their QMS that they wish to discuss Thank the auditee for their co-operation
What is Evidence?
Qualitative or quantitative information, records, or statements of fact pertaining to: the quality of the product or service to the existence and implementation of a quality management system requirement
which is based on observation, measurement or test and which can be independently verified
what was observed, examined or stated, where and when details of requirement ( standard, procedure, work instruction, specification etc.) who made what statement(s)
Objective Evidence evidence which exists uninfluenced by emotions or prejudice can be traced does not need further clarifications within the scope of the document
Observe
Check
Employees understanding of the procedures that affect their work Managers understanding of their quality objectives and progress towards meeting these objectives What happens to the system when responsible person for a job is absent from work System integrity under an emergency
Avoid
Letting personal prejudice enter the audit process Being bullied by your seniors Bullying your juniors Concealing systems irregularities due to friendships looking at the same things over & over Giving your opinions on how things should be done Being casual
Sampling
Taking Notes
Employee names and job titles Product identification Quotes and statements Rough sketches
Surroundings
Issues which may impact other functions
Observation
Types of Questions
Open Closed
Hypothetical
Obvious Answered
Use appropriate types of question Adopt a logical approach Follow a natural sequence
Communication Skills
Range of literacy
AUDIT REPORTING
An Audit Report is
A summary or record of the outcome of an audit, in line with the agreed audit objectives, scope and criteria
Never loose sight of the basic aim of an audit, namely to get management commitment to act on the findings It should be fair and balanced
Audit objectives and criteria Audit findings Audit conclusions Strengths and Weaknesses Number of nonconformities and observations, if any Recommendations, if any Obstacles encountered Follow-up activities Statement of the confidential nature of contents Audit Plan Nonconformity/Observation Reports Audit Checklists (Appendix) Identification of the lead auditor and team members List of auditee representatives
A unique reference number The agreed requirement - why it is wrong Nonconformity - what is wrong Where it was found What is necessary to put matters right Auditor name
Organisation structure Management System Standard Education and training Resources Adherence to defined processes and procedures Management leadership and support
Information
Legal & Regulatory Requirements
AUDIT FOLLOWUP
close outstanding NCs / Observations special visit next audit verify corrective action effectiveness probability of recurrence
Corrective and preventative action takes place in a timely manner Corrective and preventative action is effective and suitable The real benefits of the audit can be realised The effectiveness of the audit programme can be measured
Re-statement of audit objectives, scope, and criteria Representative sample statement Audit conclusion - executive summary Audit findings detail Follow-up activities Obtaining ownership and commitment
Reporting
Questions
Auditing as a Career
You can build a career auditing against quality, safety, environmental and legal issues Textile and Engineering sectors have a large demand for auditing services You do not need a Lead Assessor course unless you are thinking of auditing for a certification agency Specific knowledge of quality, safety, environmental and legal issues a must
Professional Qualifications
Quality Management
IRCA(UK) International Register for Certified Auditors RAB(USA) Registrar Accreditation Board
PNAC (Pak) Pakistan National Accreditation Council
Environmental Management
EARA & IEMA (UK)
You do not have the authority to question your seniors You do not have the time to read documents and write reports You do not believe in the concepts of quality management You are not looking to improve the practices employed by your company
BENEFITS
Compliance to corporate policies Easy acceptability for clients supplier evaluations Employee morale Reduced Rework
Gain management commitment Choose an implementation team Prepare a budget and schedule Assign responsibilities to cross functional teams Involve all employees Conduct preliminary reviews to identify gaps Modify plan (if required) Prepare procedures Plan for change Train employees Assess performance through audits Address gaps
Quality policy Regulatory requirements - Product specific only Objectives and targets Quality management system Structure and responsibility Training awareness and competence Communication - Internal & External Document control Operational control Purchase control and supplier development Monitoring and measurement Non conformance and corrective action Records Audit Management Review Use of Statistics & other improvement methodologies
Communication
INTERNAL METHODS
EXTERNAL METHODS
QMS Documentation
Policy
EMS Manual Procedures Forms & Drawings
Document control
Issue/revision date Effective date Approval Revision number Document number Copy number Cross references
Identify the problem Identify the cause Come up with the solution Implement the solution Document it Communicate it
QMS Auditing
Develop audit procedures & protocols Establish audit frequency Train your auditors Maintain audit records
ISO 9001:2000
8 Quality Management Principles
Clause 1.2_Application
ISO 9001:2000
8 Quality Management Principles
All requirements of this International Standard are generic and are intended to be applicable to all organisations, regardless of type, size and product provided
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organisation and its product, this can be considered for exclusion
Permissible Exclusions
ISO 9001:2000
8 Quality Management Principles
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to: requirements within clause 7, and
such exclusions do not affect the organisation's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements
It should be noted that clause 1.2 of ISO 9001:2000 is not intended to apply only to entire clauses; there may be circumstances where specific requirements within one of the sub-clauses of clause 7 are applicable, whilst others can be excluded.
Justification of Exclusions
ISO 9001:2000
8 Quality Management Principles
ISO 9001:2000
8 Quality Management Principles
7.3 (Design and development) - where the organisation has no responsibility for the design and development of the products it provides 7.5.3 (Identification and traceability) - this clause would only be partially applicable where there is no specific traceability requirement for the organisations products 7.5.4 (Customer property) - where the organisation uses no customer property in its product or product realisation processes.
Where an organisation fails to provide justification for the exclusion of specific clause 7 (Product realisation) requirements in its Quality Manual Where an organisation decides not to apply a requirement in clause 7 based only on the justification that this was not a requirement of the 1994 version of the Standard, and had not been previously included in the organisations QMS Where requirements in clause 7 have been excluded because they are not required by regulatory bodies, but this affects the organisations ability to meet customer requirements Subcontracted or Outsourced processes where the overall responsibility for product realisation belongs to an organisation
General Requirements
The organisation shall establish, document, implement, maintain and continually improve the QMS.
To implement the QMS, the organisation shall:
a) identify the processes needed for the quality management system b) determine the sequence and interaction of these process c) determine criteria and methods required to ensure the effective operation and control of these processes d) ensure the availability of information necessary to support the operation and monitoring of these processes e) measure, monitor and analyse the processes, and implement action necessary to achieve planned results and continual improvements.
ISO 9001:2000
8 Quality Management Principles
A Quality Manual shall be established and maintained, that includes the following:
- the scope of the quality management system and Exclusions (if any) - documented procedures reference - a description of the sequence and interaction of the processes included in the QMS
Management Commitment
Top management shall provide evidence of its commitment to the development and improvement of the QMS by: a) communicating to the organisation the importance of meeting customer as well as regulatory and legal requirements b) establishing the quality policy and objectives c) conducting management review d) ensuring the availability of necessary resources
Management Responsibility
Resource Management
Product Realisation
Customer Focus
Management Responsibility
Resource Management
Product Realisation
Top management shall ensure that customer needs and expectations are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction
Quality Policy
Top management shall ensure that the quality policy:
Management Responsibility
Resource Management
Product Realisation
a) is appropriate to the purpose of the organisation b) includes a commitment to meeting requirements and to continual improvement c) provides a framework for establishing and reviewing objectives d) is communicated and understood at appropriate levels in the organisation e) is reviewed for continuing suitability
Planning
Management Responsibility
Top management shall ensure that objectives are established at relevant functions and levels within the organisation. Top management shall ensure that the resources needed to achieve the objectives are identified and planned. The output of the planning shall be documented.
Resource Management
Product Realisation
Quality planning shall include: a) the processes of the QMS, considering permissible exclusions b) the resources needed c) continual improvement of the QMS d) Planning shall ensure that change is conducted in a controlled manner and that the integrity of the QMS is maintained during this change.
Objective overall quality goal arising from the quality policy Target detailed quantified performance target
Reduce waste
Management
Responsibility
Resource
Management
Improveme nt
Product
Realisatio n
Functions and their interrelations within the organisation, including responsibilities and authorities, shall be defined and communicated Top management shall appoint a member of the management, who, irrespective of other responsibilities, shall have responsibility and authority for the QMS The organisation shall ensure communication between its various levels and functions regarding the processes of the QMS and their effectiveness
Management Review
Management Responsibility
Resource Management
Product Realisation
Top management shall review the QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review shall evaluate the need for changes to the organisations QMS, including quality policy and business objectives Review Input and Output clearly defined
Provision of Resources
Management Responsibility
The organisation shall determine and provide, in timely manner, the resources needed:
To implement, maintain and improve the processes of the QMS To enhance customer satisfaction
Resource Management
a)
b)
Product Realisation
Human Resources
Management Responsibility
Resource Management
Product Realisation
Personnel who are assigned responsibilities defined in the QMS shall be competent on the basis of applicable education, training, skills and experience Provide training or take other actions Determine the necessary competence Evaluate the effectiveness of actions taken Maintain records
Infrastructure
Management Responsibility
The organisation shall identify, provide and maintain the infrastructure it needs to achieve the conformity of product quality including: a) workspace and associated facilities b) equipment, hardware and software c) supporting services (transport and communication etc.)
Resource Management
Product Realisation
Work Environment
Management Responsibility
The organisation shall identify and manage the human and physical factors of the work environment needed to achieve conformity of product Examples include organisation culture, health and safety etc. NCRs cannot be raised on health and safety and/or environmental issues
Resource Management
Product Realisation
Management Responsibility
The organisation shall plan and develop the processes necessary for product realisation In planning the processes for realisation of a product the organisation shall determine the following, as appropriate: a) business objectives for the product, project or contract b) the need to establish processes and documentation, and provide resources and facilities specific to the product c) verification and validation activities, and criteria for acceptability d) the records that are necessary to provide confidence of conformity of the processes and resulting product.
Resource Management
Product Realisation
Management Responsibility
Resource Management
Product Realisation
Determination of requirements related to the product - product requirements not specified by the customer but necessary for intended or specified use - obligations related to product, including regulatory and legal Review of requirements related to the product Customer communication
Management Responsibility
Resource Management
Product Realisation
Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes
Purchasing
Purchasing process
Management Responsibility
The organisation shall control its purchasing processes to ensure purchased product conforms to requirements Purchasing documents shall contain information describing the product to be purchased
Purchasing information
Product Realisation
Management Responsibility
Resource Management Measurement, Analysis and Improvement
Product Realisation
The organisation shall control production and service operations including the processes for release, delivery and post delivery activities Identification and traceability Customer property including intellectual property Preservation of product including identification, handling, packaging,storage and protection
Management Responsibility
Resource Management
Product Realisation
The organisation shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements, (see 7.2.1) Calibration Identification Safeguarded from adjustment Protection from damage Validity of previous results Records maintained. Computer software
Management Responsibility
The organisation shall plan, implement the monitoring, measurement, analysis and improvement processes to demonstrate
Resource Management
Product Realisation
Conformity of product Conformity of QMS and to continually improve the effectiveness of the QMS
Management Responsibility
Resource Management
timing of actions including the elimination of detected NCRs and their causes
Product Realisation
The organisation shall ensure that product that does not conform to product requirements is
Management Responsibility
Resource Management
Product Realisation
Documented procedure Identification and traceability Disposition Records shall be maintained When detected after delivery or use has started the organisation shall take action appropriate to the effects, or potential effects
Analysis of Data
Management Responsibility
Resource Management
analyse appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectivess of the QMS can be made.
Product Realisation
Customer satisfaction Conformity to product requirements Characteristics and trends of processes and products Suppliers
Continual Improvement
Management Responsibility
The organisation shall continually improve the effectiveness of the QMS through the use of the
Resource Management
Product Realisation
Quality policy Business objectives Audit results Analysis of data Corrective and preventive actions Management review
Both the ISO 9000 and ISO 14000 series of standards emphasise the importance of audits as a management tool for monitoring and verifying the effective implementation of an organisations policy for quality and/or environmental management This International Standard provides guidance on conducting internal or external QMS and/or EMS audits, as well as on the management of audit programmes It is discretionary whether or not QMS and/or EMS audits are conducted separately or together This International Standard can be applied to other management system standards