audit training_1st phase
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ISO 9001:2000 Refresher
andQuality Audit training
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Training Course Outline
Principles of Quality Management Interpreting the ISO 9001: 2000 requirements Audit programs Auditors requirements and roles Audit cycle : how to plan, conduct, and prepare
audit report
How to identify and write nonconformities
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Participants will learn: the four phases of audit how to make audits value added how to interpret the standard
how to perform process audits how to gather objective evidence how to conduct successful audit interviews
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Introduction
International Organization for Standardization is aworldwide federation of national standard bodies,with representatives from each of approximately
140 countries. The objective of ISO is to promotethe development of standardization and relatedactivities in the world with a view to
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Purpose of ISO
ISO's purpose is to facilitate international tradeby providing a single set of standards that
people everywhere would recognize andrespect
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How does ISO work?
ISO's purpose is to facilitate international tradeby providing a single set of standards that
people everywhere would recognize andrespect
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Benefits of ISO
Improved customer satisfaction Increased profits Enhanced marketplace recognition Break down of internal organization boundaries
Increased productivity as the correct data,equipment, tools and documentation are integratedinto the total process
Decreased operating cost due to fewer problems
Improved employee understanding of how ISOefforts, QMS and business strategy are aligned forimprovement
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Misconceptions on ISO
1. Some think ISO is purely documentation
2. The ISO 9000 standards tell a company how tosetup and run its business
3. If you buy products/services from an ISO certifiedcompany, this means you are getting a productor service of highest quality
4. Once certified, no further activity is necessary
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Eight Principles of QMS
1. Customer Focus2. Leadership
3. Involvement of People
4. Process Approach5. System approach to management
6. Continual Improvement
7. Factual Approach to decision making8. Mutually beneficial supplier relationship
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ISO Promotes Process Approach
Q. What is process approach?
A. Identifying and managing the linked activitiesthat meets customer requirements to enhancecustomer satisfaction
Processes are interconnected because the
output from one process becomes the inputfor another process.
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ISO Requirements
Section 1.0 Scope of QMS
Section 2.0 Normative reference
Section 3.0 Terms and definitions
Section 4.0 Documentation requirements
Section 5.0 Management responsibilitySection 6.0 Resource management
Section 7.0 Product realization
Section 8.0 Measurement, analysis andimprovement
Requirement of the standards
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Interpreting ISO 9001
Requirements
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Clause 4.0 QMS Requirements
- implement, document and maintain a QMS- identify the processes needed for QMS and its
interaction
- determine the criteria and methods to control these
processes
- ensure availability of resources and information
- measure, monitor, and analyze the processes
- achieve planned results and continualimprovements
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Documentation Requirements
- documented statements of quality policy andquality objectives
- quality manual- documented procedures required by the
international standard- documents needed by the organization to ensure
effective planning, operation, control of itsprocesses
- records required by the international standard
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Documented Procedures
Required by ISO 9001:200 Control of documents Clause 4.2.3
Control of records Clause 4.2.4
Internal audit Clause 8.2.2 Control of nonconforming product Clause 8.3
Corrective action Clause 8.5.2
Preventive action Clause 8.5.3
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Documents Needed by the Organization
Specifically referenced in ISO 9001:2000
Quality policy Clause 4.2.1a
Quality objectives Clause 4.2.1a Quality Manual Clause 4.2.1b
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Additional Documentation
There are several requirements of ISO 9001:2000where an organization could add value to itsQuality Management System and demonstrate
conformity by the preparation of other documents
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Additional Documentation of ATI
Production procedures and Work instruction
guidelines HR, IT and Purchasing procedures
Customer complaint
Measurement analysis Customer satisfaction
Change request
Quality assurance Process maps, organization chart
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Records
All records have to be controlled in accordance
with the requirements of Clause 4.2.4
Records are to be controlled as evidence toconformance to requirements and of effective
operation of QMS Records need to be legible, properly stored and
protected, readily identifiable and retrievable
Organization are free to develop records that maybe needed to demonstrate conformity of theirprocesses, products, and QMS
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Required Records
Clause Records Required
5.6.1 Management reviews
6.2.2e Education, training, skills and experience
7.1d Evidence that the realization processes andresulting product fulfill requirements
7.2.2 Results of product requirements review andactions arising from the review
7.4.1 Results of supplier evaluation and actions
arising from evaluation 7.5.2d To demonstrate process validity where
output can not be measured
7.5.3 Unique identification of a product
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7.5.4 Customer property
7.6a Basis for calibration of measuring equipment 7.6 Validity of previous results when measuring is
found not to conform to its requirements
7.6 Results of calibration of measuring equipment
8.2.2 Internal audits
8.2.4 Evidence of product conformity based fromacceptance criteria
8.3 Nature of product nonconformity
8.5.2 Results of corrective action
8.5.3 Results of preventive action
. . . records
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Documentsare the future they tell you what to do or
how something is done
Records are the history of what you have done.
Records are the proof you need to show that youfollow your quality management system.
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Clause 5.0 Management Responsibility
- the quality policy shall be defined, documented,understood, implemented and maintained
- develop, implement and improve QMS
- formulate measurable quality objectives establishat relevant levels in the organization
- responsibilities and authorities are defined andcommunicated within the organization
- identify and meet customer requirements and
enhance customer satisfaction- evidence that management is committed to QMS,
customer/legal requirements, and continualimprovement
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plan, implement monitoring, measurement,analysis and improvement processes
define the method for monitoring customerperception as to whether customer requirementshave been met
identify and control nonconforming products determine, collect and analyze data
conduct internal audits at planned intervals continually improve effectiveness
Clause 8.0 Measurement, Analysis andImprovement
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What is Quality Audit
Systematic, independent and documentedprocess for obtaining audit evidence and
evaluating it objectively to determine the extentto which audit criteria are fulfilled
- Definition from ISO 9000:200
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Internal Quality Audit is a powerful tool for any business to measure the effectiveness of theQuality Management System. It is also a good
management tool that can be used to review the processes and identify any weaknesses, risks andareas of improvement
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Principles of auditing
1) Ethical conduct
2) Fair presentation
3) Due professional care
4) Independence
5) Evidence-based approach
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Basic Types of Audit
Internal First Party audit External
Supplier Audit Second Party auditIndependent Organization - Third Party
(Registrar)
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IQA Requirements: Plan the audit program considering status and
importance of processes and areas and previousaudit results Determine audit criteria and scope Define audit frequency and methods per Quality
Manual yearly or as needed Select impartial and objective auditors Conduct audit at planned intervals Assess for conformity and effectiveness Maintain documents related to internal audit Ensure timely and effective corrective action Verification of Corrective Action
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Audit Objectives
1) To determine to what extent our QMS: Achieves its objectives Conforms to company requirements Complies with regulatory standards
Meets customer's requirements1) To improve the efficiency and effectiveness of
our QMS
3) To verify if our QMS continues to meetrequirements
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When to do an Audit The client may initiate an audit because:
A regulatory agency requires an auditA previous audit indicated that a follow-up
audit is necessary
An auditee has made an important changes in: Policies or procedures Technologies or techniques Management or organization
An auditee may carry out audits on a regular basisto improve quality system performance or toachieve business objectives
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How to Add Value
To make this IQA a value-added audit, the process shouldfocus more on QMS capability and effectiveness rather than
compliance
A. Adding value means to make something moreuseful
Q. What do we mean by adding value?
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Some tips on how to add value
Audit planning understand the auditee's expectations / corporate
culture communicate concerns on previous audit result
appropriate audit team selection to achieve auditobjectives adequate time allocation
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QM Responsibilities
to ensure that audit procedure is carried out andcontrol the frequency and implementation of
quality audits
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Auditor's Role
Evaluate the QMS Carry out assigned audit tasks Comply with audit requirements Respect all confidentiality requirements
Collect evidence about the QMS Document audit observations and conclusions Safeguard audit documents, records, and reports Find out if the quality policy is being applied
See whether quality procedures are beingfollowed
Detect evidence that might invalidate audit results
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Auditors areNOT
Inquisitor Fault finder Rock Thrower
Avenging angels (biased for or against) Dishonest Overactive
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Professional Conduct
Auditors must: have integrity and be independent and objective
have the authority they need to do a proper job be willing to listen to others be able to communicate effectively with personnel at
all levels avoid compromising the audit by discussing audit
details with auditee during the audit
Auditors must behave in a professional manner.
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Personal Attributes
An auditor should be:1) ethical fair, sincere, honest and discreet2) open-minded willing to consider alternative ideas or
points of view3) diplomatic tactful in dealing with people
4) observant actively aware of physical surroundingsand activities
5) perceptive instinctively aware of and able tounderstand situations
6) versatile adjust easily to different situations7) tenacious persistent, focused on achieving objectives
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Four Phases of Audit
Phase 1 Audit Planning
Phase 2 Audit Execution
Phase 3 Audit Reporting
Phase 4 Verification and Follow-up
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What Who
Input WhatOutput
Method Measures
Process
What (resources)equipment, tools,software
Inputwhat is received,
when, from whom
Methodprocedures, forms,instructions
Who (resources)people, skills,experience
Outputwhat is delivered,
when, to whom
Measuresquality objectives,performance results
Process Diagram
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No one plans to fail, but sometimes we fail to plan
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Audit Step Card
1] Audit assignment2] Review documents and plan the audit3] Confirm audit plan4] Interview Dept Manager
5] Review documented process floor audit6] Review an undocumented process7] Summarize results with Dept Manager8] Write CPARs and audit report
9] Submit report / verification
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1. Prepare audit plan - define the objectives, scopeand audit criteria
2. Determine the audit team3. Notify the auditee and confirm schedule
4. Perform an initial document review procedures,records of CPAR, previous audit findings
5. Prepare necessary working documents for theaudit audit notice, audit checklist
Audit Planning
A dit ti
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Audit execution
1. Start the audit by having an opening meeting and
explain objectives2. Define the role of guide or observer (if there's any)
3. Interview people at their workplace
4. Put the person at ease
5. Explain your purpose
6. Ask about job and applicable documents
7. Use open-ended questions (5 Ws and H)
8. Verify responses9. Remember to ask for proof
10. Observe activities and examine record
dit ti
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11. Take random, yet representative sample
12. Follow trails to other areas based on scope
13. Check the facts (use other sources)
14. Record the evidence (checklist notes)
15. Make tentative conclusions
16. Give opportunity to discuss other subjects17. Avoid consulting on cause and solution
18. Thank for time and cooperation
19. Review progress periodically with audit team
20. Compare audit evidence to audit criteria
21. Generate findings and prepare conclusions
22. Conduct closing meeting and report results
. . . audit execution
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Objective evidence
Data supporting the existence or verity ofsomething Clause 3.8.1 of ISO 9000:2000
May be obtained through observation ,measurement, test or other means
Does not necessarily depend on documentedprocedures, records or other documents exceptwhere specifically required by ISO 9001:2000
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Evidence identify source
If person name and title, dept and manager If document document name, revision number and
revision date If record identify record, record date
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Audit Reporting
1. Prepare the preliminary audit report (Auditor)
2. Prepare the final audit report (Lead Auditor)
3. The report includes: the detailed audit plan
review of the evidence that was collected list of nonconformities that were identified
judgment about how well the QMS complies with allquality system requirements
assessment of the QMS's ability to achieve qualityobjectives and apply the quality policy
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4. Approve audit report5. Issue audit report and CPAR (if necessary) in
agreed time frame
. . . reporting
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Verification and Follow-up
1. Agree with proposed corrective action2. Conduct follow-up audit to ensure that
action is taken on agreed time frame and to
evaluate its effectiveness3. Evaluate the effectiveness of action taken
4. Close out nonconformity based on action
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Auditing Service Organization
Service is the result of at least one activitynecessarily performed at the interface betweenthe supplier and customer and is generallyintangible.
Provision for service may involve: an activity performed on a customer-supplied
tangible product (car for repair) an activity performed on a customer-supplied
intangible product ( delivery of an intangible product creation of ambiance for the customer
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Auditing Clause 4.0
Audit for: definition of needed documents (internal and external
sources) distribution of documents to those that need to know control of documents for current revision level with
emphasis on control of customer-driven changes dissemination of changes throughout all affected
documents
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Auditing Clause 4.0
ISO requires that: The organization has an updated and continually
improved QMS Processes must be identified Sequences of operations are determined Ensure that processes are working properly Ensure that there is sufficient resources QMS is monitored and improved
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Auditing Clause 5.0
5.1 Management commitment management's commitment to the development andimprovement of QMS is defined
Quality policy and quality objectives are establishedand relevant
Had conducted management review There is sufficient resources to achieve what was
planned
5.2 Customer focus
Management's commitment to determining, meetingand enhancing customer satisfaction is defined
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Auditing Clause 6.0
How does the organization ensures that enoughresources are being directed to improve theservices that they offer?
How does IT identifies the need to add the current
infrastructure? When in place, how are theymaintained?
Are work areas properly controlled for lightingand climate conditions? Are work areas organized
and provide safe working conditions?
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Auditing Clause 7.0
7.1 Planning of product realization There is a plan on how existing products/services will
be produced or supplied Processes are monitored and measured
7.2 Customer-related processes Customer requirements are determined
7.4 Purchasing How are suppliers accredited and evaluated
7.5 Validation of processes for production and
service provision
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Auditing Clause 8.0
1. ISO requires how information is obtained to getcustomer perception?
2. Effectiveness of Internal audit3. Effectiveness of the methods applied
A dit Q ti
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1. What is the primary purpose of this process?
2. Who is the process owner?3. What is its inputs and who supplies them?
4. How would you know if these inputs are good?
5. What are your responsibilities in this process?6. What trainings and skills are needed?
7. How is the process monitored and controlled?
8. What are its outputs and who receives them?
9. Do these outputs meet requirements?
Audit Questions:
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10. What do you do if the outputs do not meetrequirements
11. How do you measure the process performance?
12. What are the process quality objectives?
13. Ask for the records
14. How could this process be improved?
. . . questions:
Terms and terminologies
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Audit conclusion outcome of an audit, provided by theaudit team after consideration of the audit objectives andall audit findings
Audit criteria set of policies, procedures or requirementsAudit evidence records, statements of fact or other
information, which are relevant to the audit criteria
Audit findings results of the evaluation of the collectedaudit evidence against audit criteria
Audit plan description of the activities and arrangementsfor an audit
Audit program set of one or more audits planned for aspecific time frame and directed towards a specific
purposeAudit scope extent and boundaries of an audit
Terms and terminologies
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Auditee organization being auditedAuditor person having the competence to conduct an auditCompetence demonstrated personal attributes and
demonstrated ability to apply knowledge and skills
Conformity is all about meeting requirementsCorrection the action taken to eliminate a detected
nonconformity
Corrective action are steps that are taken to removethe causes of an existing nonconformity or otherundesirable situation. It addresses actual problem
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Procedure Audit
1. Start by selecting a procedure for audit2. Define the scope of audit, assign an auditor and
prepare a brief audit plan
3. Identify the inputs that are used by this processand the outputs that are generated
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