AUDIT TRAINING_1ST PHASE

8/4/2019 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

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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