Training for the internal audit of ISO 9001 (Quality Management System) and ISO 14001 (Environmental Management System) standards

Date: 25 November 2024, Monday

Time: 9 am - 5:15 pm

Venue: My company at Taman Teknologi Johor, Senai

Trainer: William Chong from Flexiplus Training & Consulting Plt

Attend by 16 pax: Managers (PMC, Production), Engineers (QA, QMS, IE, PE), Supervisors (LPP, warehouse) and Executive (CS, Purchasing, HR, Maintenance, IT, warehouse) in organization

What is an audit?

Systematic, independent, and documented process for obtaining auditing evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.

- ISO 19001 Def. 3.1

• Systematic: got sequence
• independent: without influenced by other people
• audit evidence: picture, video
• objectively: 客观

No evidence, don't write in report

Finance is not involve in ISO audit

Internal audit at least need to do once a year

Subjective - among all of you, who is the most biggest size person

Objective - among all of you, who is the most heavy person

How many major NCR to fail ISO audit?

Answer: Two major NCR

QMS Audit Objectives

• To determine conformance with QMS audit criteria
• To determine proper implementation and maintenance of QMS
• To identify areas of potential improvement, on a risk-based approach
• To assess ability of management review to ensure continuing suitability and effectiveness of QMS
• To evaluate suppliers' QMS

Definitions (from ISO 19011:2018)

Conformity - fulfillment of specified requirements

Audit Findings - results of the evaluation of the collected audit evidence against audit criteria

Audit Evidence - records, statements of fact or other information, which are relevant to the audit criteria and verifiable

Nonconformity - non-fulfillment of a specified requirement

Risk - effect of uncertainty

Competence (能力) - ability to apply knowledge and skills to achieve intended results

Audit Criteria

• The QMS Standard - ISO 9001
• requirement of ISO
• Your documented Quality Management System
• L1 MANUAL
• Policy, Objective, Target
• L2 PROCEDURE
• what to do
• L3 Work Instruction / SOP
• how to do
• L4 FORMS (表格), RECORDS
• Compliance Obligations
• law
• example: traffic police need to know the law
• Company standards
• only apply big company like Google

CA = corrective action

PA = preventive action

Why Audit?

The formal requirements are aimed at verifying the compliance and effectiveness of specified requirements which are also known as 3 P's.

Principles of Auditing - 3P's

The 3 P's:

• People
• competency people
• Practice
• buat betul tak
• Paper
• record / check list
• Form prepared by
• Form verify / approve by
• every form must have document number
• every form must have revision number
• every form must have title

First decide where to audit

Then decide what process to audit

Principles of Auditing - ACE

The whole point of being an internal auditor is to check the ADEQUACY, COMPLIANCE, EFFECTIVENESS of the management system.

ACE:

• Adequacy 充足性
• Standards to Work Instructions & Procedures
• Transfer all the requirement to documentary
• Compliance 遵守
• do what you write
• Effectiveness 效力
• effectiveness of result compare to target & KPI

Auditor Vocabularies

• Lead Auditor - an auditor who has the extra responsibility of managing an audit
• Auditor - person qualified to perform audits
• Auditee - organization being audited
• Audit client - organization or person requesting an audit
• Audit Team - one or more auditors conducting an audit supported if needed by technical experts
• Technical Experts - person qualified to perform audits

Ofi = Opportunity for improvement

Phases of Audit

• Initiation
• Preparation
• Execution
• Reporting
• Follow-up
• back to Initiation

Audit Initiation

• Appoint the Audit Team Leader
• Define Objectives, Scope and Criteria
• Determine Feasibility 可行性
• Select Audit Team
• Establish initial contact with Auditee

Audit Preparation

• Prepare Audit Plan
• Assign Work to Audit Team
• Prepare work Documents
• audit note
• check list (what? when? where? why? how? who?)

Conducting the Audit

• Opening Meeting
• Collection of Audit Evidence
• Preparing Audit Conclusions
• decide whether is NCR or conformity or OFI
• Closing Meeting

Questioning - The Filter Funnel

• Open questions
• Encourage auditee to talk freely
• Use what, where, when, why, how, and who
• eg: What do you do?
• Probing questions
• Follow-up or focusing on more precise details
• eg: What about this?
• Closed questions
• Used where you want a clear 'yes' or 'no' answer
• eg: Is it true ...?

Auditor's Friend - the crunch question

• Show me