PRESENTED BY

MUHAMMAD ASIM B .E HAMDARD UNIVERSITY

MBA IQRA UNIVERSITYLEAD AUDITOR TUV AUSTRIA

Core Knowledge about QMS (Quality Management

System)

What is QMS?

A Quality Management System (QMS) is a

collection of business processes focused on achieving your Quality Policy and Quality Objectives i.e. what your customer wants and needs. It is expressed as the organizational structure, policies, procedures, processes and resources need to implement Quality Management System.

What is an Audit ?

Audit is a systematic, independent, planned and documented activity performed by qualified personnel to determine by Investigation, Examination, or Evaluation of Objective Evidence, the adequacy and compliance with established procedures, or applicable documents, and the effectiveness of implementation of QMS.

Types of Audit

First Party Audit The company Audit its own system (Internal

Audit)

Second Party AuditCustomer based Audit (because of Commercial

Interest)

Third Party AuditAn Independent body certifies an Organization.

What is an Auditor ?

An auditor is a professional who is responsible for Evaluating or Examining some aspects of a project, business, organization or any individual.

Auditor guidelines ISO 19011:2011

Discussion on following Terms useful for an Auditor

Audit Criteria (Policies, Procedures)Audit Evidence (Objective evidence)Audit Team (Members)Audit Client (Organization)Audit Findings (Conformance or Non-

Conformance)Audit scope (depend upon organization

structure)Audit plan (Plan Activities & Arrangements)Audit Checklist (List of Task’s)Risk (Uncertainty)Audit Conclusion (Outcome)

An Auditor must be aware about

Audit PlanAudit ChecklistAudit Summary ReportAudit Sampling MethodBoundaries of an AuditRecommendationRoles and Responsibilities

Auditor Behavior must be

Ethical (Truthful)Open minded (Alternatives)Broad minded (Ideas)Diplomatic (Tactful)Observant (follow)Decisive (Logical thinking)Self reliant (Independently)Perceptive (Understand situation)

Audit Trick

Ask (Mainly open ended question which provide information).

Look (Observe what is happening)

Check (Availability of procedures, awareness of Auditees, Conformance of procedures, consistency)

Record (The Objective evidence Positive & Negative)

Performing an Audit Program

Initiating the Audit (Contact with client and determine feasibility).Preparing an Audit Activity (Document review, Audit Plan, Distribution of

Activity.)Conducting an Audit Activity Opening meeting, demand of guide (Auditee),

document verification, collection of information.Meeting of all Auditor’s (Info. Collection)Preparing Audit Conclusion.Closing Meeting ( Discuss all NCR’s with Auditee)Preparing and Distribution of Audit Report.Must ensure the follow-up on NCR’s.

Difference b/w Continuous Improvement and Continual Improvement

Discuss and illustrate Graph

08 Principles of Quality Management

LeadershipInvolvement of PeoplesCustomer focusProcess Approach (relates to productivity)System Approach (relates to QMS)Factual Approach to Decision MakingContinual ImprovementMutually beneficial supplier relationship

08 Clauses of Quality Management System (ISO 9001:2008)

1 - Scope2 - Normative reference3 - Terms and Conditions4 – Quality Management System General requirementsDocumentation requirements5 – Management Responsibility Customer Focus Quality PolicyPlanningQuality ObjectivesResponsibilities, Authority & CommunicationsManagement Representative.

08 Clauses of Quality Management System (ISO 9001:2008)

Management Review6 - Human Resources Competence, training and awareness Infrastructure Work environment7 – Product Realization Customer related processes Design and Development Purchasing Product and service provision8 – Measurement, analysis and improvements. Internal Audit Analysis of Data Control of Non-Conforming Product Corrective Actions Preventive Actions

Discussion

Relationship of 08 Principles of Quality Management.

With

08 Clauses of Quality Management System

ISO 9001:2008

Mind Mapping Questions

What is Factual Approach to Decision Making ?

Identify minimum Four Clauses that support such an approach?

Identify two ways in which an Auditor can verify that agreed corrective actions have been

implemented ?

The level of customer satisfaction is one measure of the

performance of a Quality Management System.

List Two methods which can use to determine its satisfaction

level?

Continual Improvements

Continual Improvemen

ts

Quality Policy

???

???

Quality Objectives

???

???

Situation # 01

At opening meeting of an External Audit, MR inform you that a recent Internal Audit has found many non-conformities relating to the in-house purchasing department.

Corrective Action has already been planed. The MR suggested that to Audit this department again would add no value and ask if you could delete this depart from Audit Plan and spend more time in production area.

Is it correct ??? If not then outline at least four issues that can be face.

Situation # 02

During a routine Audit visit, Auditee of Design and Development department informs you that they no longer carry out any design work. The activity is now outsourced to a contractor.

Give four examples of Audit Evidence you would look for determine the conformance of the current system with ISO 9001.

Must mention Clauses of ISO 9001 standard that relates to this situation.

Situation # 03

During an Audit of an Insurance co. you ask Training Manger to show training record and you found that all employees attend trainings.

You ask that how they are evaluated, manager replies that we evaluate via questionnaire after completion of each training.

You did a sampling audit and examine 03 questionnaire, and surprisingly all 3 persons got highest marks and awarded satisfactory score from Trainer.

What is your Thinking ??? Express in your words ???Is this NCR or Audit Trail ???

Situation # 04

You are Auditing a design department of Industrial equipment.

They are currently dealing with a serious customer complaint relating to faulty safety mechanism, and their engineers have some difficulty in repairing of safety mechanism due to the Old drawing issue and drawing does not contain modification step of safety mechanism, Engineer’s opinion is to incorporate modification step in drawing.

Manager reply that it is not recorded due to some minor changes and did not affect customer contract.

What is your Opinion ????Is this a Major non-compliance or not ???Raise NCR or perform Audit Trail ???

Situation # 05

You found a problem during Audit at Testing department that the word ‘OK’ is written with initial of junior inspector on testing report.

You ask with supervisor that Who has authorized to test and release this product, and he replied that authorization is not necessary in routine product, and it is clear from Chief Inspector if any abnormality or a problem is occur.

You verify the documented procedure and found that Chief Inspector is responsible for authorizing final release of all products.

What is happening there ???Is this NCR or Audit Trail ???

Preparation of Checklist with reference to Standard Clause

You are conducting an ISO Audit in an Injection Molding company (a process by which components are manufactured). The next activity on your Audit Plan is the organization Final Inspection and Testing department.

Outline your checklist on a paper with clause reference