how to conduct qms audits effectively...1 © 2019 3fold education centre . all rights reserved ....

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© 2019 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD

HOW TO CONDUCT

QMS AUDITS EFFECTIVELYas per ISO 9001:2015 & ISO 19011:2018

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INTRODUCTION

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Objectives

• Basic Terms & Definitions

• Introduction to QMS & Audit

• Purpose & Benefits

• Stages of Audit (PDCA)

• AUDIT PROCESS

Audit Programme

Audit Plan, Audit Checklist

Opening Meeting, Nonconformity Report

Closing Meeting, Audit Report, Closure, Follow Up

• Auditor Competence Development

• Golden Rules of Audit

• Critical Success Factors

• Clarifications / Questions


7 Quality Principles

QMP 1 – Customer focusQMP 2 – LeadershipQMP 3 – Engagement of peopleQMP 4 – Process approachQMP 5 – ImprovementQMP 6 – Evidence-based decision makingQMP 7 – Relationship management

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Objectives & Benefits of QMS Audit


Objectives & Benefits

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• Ensure Conformity

• Check Effectiveness of QMS

• Identify the Opportunities for Improvement

• Quality Performance & Culture Enhances

• A system for certification / future learning

• To capitalize opportunities and neutralize threats

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Terms & Definitions

• Audit Organization

• Customer

• Supplier

• Audit

• Audit Types

• Audit Criteria

• Audit Scope

• Competence

• Quality

• QMS

• ISO 9001

• ISO 19011

• Conformity

• Nonconformity

• Compliance

• Observations


Key Terms & Definitions related to audit :

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• Audit: Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled

• Audit Scope: Extent and boundaries of an audit

• Audit Criteria: Set of requirements used as a reference against which objective evidence is compared

• Audit programme: Arrangements for a set of one or more audits planned for a specific time frame and directed towards a specific purpose

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Key Terms & Definitions related to audit:

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• Audit Plan: Description of the activities and arrangements for an audit

• Objective evidence: Data supporting the existence or verity of something

• Risk: Effect of uncertainty on objectives

• Conformity: Fulfillment of a requirement

• Nonconformity: Non-fulfillment of a requirement

• Competence: Ability to apply knowledge and skills to achieve intended results


Framework - ISO 9001:2015 Annex SL, Appendix 3 The ten clauses

1)Scope 2)Normative references 3)Terms and definitions4)Context of the organization 5)Leadership 6)Planning 7)Support 8)Operation 9)Performance evaluation 10)Improvement

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Linkage to ISO 9001 2015



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© 2019 3FOLD Education Centre . All rights reserved . [email protected] . www.3foldtraining.com . 800 3FOLD16

ISO 19011:2018

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ISO 19011:2018


ISO 19011:2018

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Stages of Audit

Check lists

Audit Team Briefing

AuditorTraining / Qual

Audit Team

Decision

Training Materials

Roles & Resp.

Preparation

Audit Plan

Opening Meet

Conductance

Auditing

Closing Meet

Individual Reporting

Consolidated Reporting

Communicate the Report

Follow up

Corrective Actions

Follow Up

Input to MRM

Audit

Preliminary

Pre-Audit Post-Audit

Scope & Criteria

Actions & Improvements


AUDITOR SKILLS & ATTRIBUTES

Attributes• Ethical,

• Open-minded,

• Diplomatic,

• Punctual,

• Professional

• Versatile,

• Tenacious,

• Un-biased

SKILLS• Planning

• Listening

• Observing

• Interview

• Analyzing

• Reporting

• Reviewing

• Judgment

KNOWLEDGE • Process / Function

• Compliance Requirements

• Criteria

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Documented Information

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Audit Check-List

• What is a Checklist

• Contents

• Advantages

Audit Programme

• What is an Audit Programme

• Contents

• Advantages

Audit Plan

• What is an Audit Plan

• Contents

• Advantages

Nonconformity Report

• What is Nonconformity Report

• Contents

• Advantages & Closure

Audit Report


AUDIT PROGRAMME

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AUDIT PLAN


Checklist – Purchase Process

SL #

Cla

use

#

Check-Point or Subject of Audit Objective Evidence

Po

siti

ve

Co

nfo

rma

nce

OFI

Ob

serv

atio

n

Min

or

NC

Maj

or

NC

Rem

ark

s

01 8.4.1 Are the approved suppliers listed? √

02 8.4.1Do you have the criteria and records on the selection of

External providers? Check.√

03 8.4.1Do you have the criteria and records on the evaluation

of External providers? Check.√

04 8.4.2Are the controls for the external providers defined and

complied?√

05 8.4.2Scope of externally provided products/services and

extent of control - Are they defined and monitored?√ √

06 8.4.2Product or service verification plan and records are

available adequately?√ √ √

07 8.4.3

P.O or Specs about the product or service including the

requirements on Quality, Quantity, Delivery Time,

Verification, etc. defined and documented?

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Audit Checklist – Clause 9 Performance Evaluation


QMS Nonconformity Report

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1) Closing Meeting 2) Audit Report3) Correction4) Corrective Action5) Closure 6) Follow UP

After conducting the QMS ……


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Follow Up

Agreed Corrective Action Plans are followed

up by the Auditor, usually in a scheduled

review/next audit


Auditor Competence Development

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• Auditors shall be competent

• Criteria for competence to be defined

• Competence development programs & Refresher

• Auditing ability is more important

• Avoid “One Man Army” approach

• Auditor independence to be ensured

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Golden Rules of Audit

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• Check for conformity, effectiveness and improvement

• Value addition is important

• Talk less & Listen more

• Be diplomatic as well as Professional

• Communication, Coordination & Follow up shall be effective


Golden Rules of Audit

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• Identify the improvement areas

• Don’t look for NCs always

• No blame culture

• Don’t run behind the papers

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Critical Success Factors - Leadership

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• Leadership Commitment

• Empowerment for the Audit Team

• Enforcement within organization

• Top Management shall set an example to respect the Audit

• Communication and Support for the audit


Critical Success Factors – Middle Managers

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• Cooperate with the Audit Plan

• Allow the staff for their respective roles

• No personal issues, only teamwork

• Transparency required

• Don’t exhibit the attitude “My Dept. is better than yours”

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Critical Success Factors : Audit Team

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• Competence development (Cross functional)

• Auditor Vs. Employee role

• Audit beyond a checklist

• Communication, Coordination & Follow up shall be effective

• Focus value addition than completing the task


Critical Success Factors : Process Owners

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• Transparency during audit

• Corrective Actions – Effective / Timely

• Pro-active feedback till close-out

• Seek value addition rather than saving faces

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Objectives Achieved?

• Basic Terms & Definitions

• Introduction to QMS & Audit

• Purpose & Benefits

• Stages of Audit (PDCA)

• AUDIT PROCESS

Audit Programme

Audit Plan, Audit Checklist

Opening Meeting, Nonconformity Report

Closing Meeting, Audit Report, Closure, Follow Up

• Auditor Competence Development

• Golden Rules of Audit

• Critical Success Factors

• Clarifications / Questions


Clarification… If any?

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