Course overview
If you need to (i) understand the requirements of any QMS (Quality Management System) Standard, and (ii) conduct internal/supplier audits audits – then this is the course for you!
After completing this 2-day practical course & workshop participants will have the knowledge and skills to plan, undertake and report on internal and supplier audits using the process approach against any audit criteria (i.e. International 'sector-specific' Quality Management System standards, customer requirements, regulatory requirements, etc.). The aim is to evaluate both conformity (compliance) to requirements and overall system effectiveness – i.e. planned activities and planned results.
Specifically, this course is applicable to the following 'sector-specific' standards –
ISO 9001 – general manufacturing and service
AS9100 – aerospace and related defence
IATF 16949 – automotive and motorsport
AQAP 2110 – defence (NATO/UK MOD) supply chain
AQAP 2310 – aerospace defence (NATO/UK MOD) supply chain
IRIS (ISO 22163) – global rail supply chain
Participants obtain an understanding of the requirements by mapping them to an organization’s processes and activities, and then devising audit questions to evaluate the extent of conformity.
Particular attention is given to creating these 'evaluation questions' in situations where the auditee organization may not have documented procedures, or the auditor doesn't have the time to read their procedures! In addition, participants will learn how to assess the ‘active’ management of customer satisfaction, QMS and suppliers performance and process-level effectiveness – and how to audit the organization's Leadership!
This practical course contains many Team Exercises and Individual role-play scenarios that are structured to follow the key steps in preparing for, undertaking, reporting on and closing-off process-based conformity, compliance and performance audits. In this way participants gain an in-depth understanding of standard requirements – its learn-by-doing or 'Accelerated Learning'
The course timings are – 08:30 to 17:00 each day.
Course details
During the sessions, particpants will need to make reference to their personal copies of relevant ISO 9001-based QMS (quality management system) standards.
Within this course, the following sections are covered:
Auditing-related terms, definitions and methodologies
What is an internal audit?
Explanation of audit-related terms
Test: explanation of audit-related terms
Understanding interested parties and their requirements
Guidelines and Standards relating to auditing
Relationship between elements of the QMS
Understanding QMS processes
Test: identifying types of QMS process
Examples of QMS process types
Visualizing QMS processes – sequence and interaction
Test: evaluating an organization’s description of its QMS processes and their sequence and interaction
QMS business benefits
Understanding the organization and its context
Test: Organization purpose, strategic direction & scope
Audit questions focused on purpose, strategic direction & scope
Benefits of a formal QMS
Test: identifying the benefits of a formal QMS
QMS documentation
AS9100 QMS documentation requirements
Policy ~ Processes ~ Procedures
Identifying ISO 9001 need for documented information
Test: identifying ISO 9001 need for documented information
Determination of the processes needed for the QMS
Test: defining policy, processes & procedures
Auditing using a 'process-based' approach
Deriving process-based audit questions from applicable audit criteria
Deriving audit questions from audit criteria
Test: deriving audit questions from audit criteria
Turtle diagram – visualization tool for process-based QMS internal auditing
Test: identifying the ‘elements’ of a Turtle diagram
Deriving process-based audit questions from Turtle diagram ‘limbs’
Test: mapping audit questions to Turtle diagram 'limbs'
Content and structure of ISO 9001-based standards referring to the P-D-C-A cycle
ISO 9001 content: clauses and requirements
ISO 9001 HLS (high level structure): referring to the P-D-C-A cycle
Test: Locating requirements for OPERATION, SUPPORT and ANCILLARY processes
Understanding and auditing the ‘effectiveness’ of a QMS
Auditing QMS ‘effectiveness’
Requirements for QMS ‘performance’
Test: locating specific requirements for monitoring
Auditing process effectiveness – the ‘PEM’
Conducting an effectiveness audit
Test: scoring process effectiveness – the ‘PEAR’
Auditing conformity of a QMS
Understanding ‘conformity’ with QMS requirements
Test: locating ISO 9001 requirements for auditing purposes
Requirements for OPERATION processes
Test: locating ISO 9001 clauses applicable to OPERATION processes
Test: auditing MRB actions with customer-supplied nonconforming product
Requirements for SUPPORT processes
Test: locating ISO 9001 applicable to SUPPORT processes
Requirements for ANCILLARY processes
Test: locating ISO 9001 applicable to ANCILLARY processes
Auditing performance (P-D-C-A)
Quality objectives define QMS ‘performance’
Test: understanding quality objectives
Auditing quality objectives and the P-D-C-A cycle
Test: auditing customer satisfaction
Test: auditing supplier performance
Auditing risk-based thinking
Understanding/auditing risk-based thinking
Auditing risk-based thinking – “things to consider” ~ ISO 9001 clauses
Exercise: auditing risk-based thinking – “things to consider” ~ AS9100 clauses
Identifying and auditing risk sources and related methodologies
Test: operation process risks and things to look for
Audit planning
Audit planning considerations
Identifying ‘audit trails’
Test: establishing an internal audit plan
Different audit methods
Test: identifying different audit methods
Auditing the planning of an internal audit program
Guidance for estimating adequate time to conduct a full internal audit program
Test: estimating the time to conduct a full QMS internal audit
Justifying an audit program
Test: auditing the internal audit program
Planning and conducting a remote audit
Creating an audit work document
Creating an audit work document – format and contents
Personal assignment: creating an audit work document
Creating an audit work document from a Turtle diagram
You’re now ready to undertake an internal audit!
Conducting an opening meeting
Purpose of an opening meeting
Agenda items for an opening meeting
Personal assignment: creating an opening meeting agenda
Conducting an opening meeting
Test: opening meeting dos & don'ts
Performing the internal audit
The ‘evidence-based approach’ to auditing
Audit sample size determination
Test: choosing an appropriate sample focus (operators)
Test: choosing an appropriate sample criteria (POs – purchase orders)
Test: choosing an appropriate sample size (FAIRs – First Article Inspection Reports)
Managing interviews and recording evidence
Format and style of audit questions
Test: turning closed questions into open questions
Building rapport with the auditee
Auditing top management ~ “don’t be intimidated!”
Personal assignment: auditing top management and management review*
Collecting, evaluating, and recording objective evidence
Audit process summary – auditor & auditee activities
Test: dealing with auditee disagreements
Evaluating audit evidence and creating effective NCRs
Criteria for determining nonconformities
Reporting nonconformity using a nonconformity report (NCR)
Test: sections of the 'NCR Template'
Recording multiple instances of nonconformities on a single NCR
Test 1: identifying the applicable clause and formulating an effective NCR
Test 2: identifying the applicable clause and formulating a effective NCR
What if there’s insufficient evidence to determine – conformity? Or nonconformity?
Grading NCRs
Test: grading NCRs (minor/MAJOR)
The ‘mock’ audit’ (Case Study material)
Mock audit of major operation process
Preparation for/conducting the mock audit (120-min)
Exercise: On-site/Human interaction
30-min per team face-to-face with tutor
10-min to 15-min per student with tutor
Concurrent team activities – simulated audit scenarios
Preparing for, and presenting, a closing meeting
Reviewing the audit findings and preparing conclusions
Conducting closing meeting
Personal assignment: creating a closing meeting agenda
Reporting the audit results
Audit report purpose and content
CB audit report contents
Test: Key items in the internal audit report
Conducting audit follow-up
Reminder: correction vs. corrective action
Responsibility for corrective actions
Test: NCR terminology and actions
Verifying the effectiveness of corrections and corrective actions
Test: verification of actions/corrective actions
Auditor selection, competence, and personal qualities
Responsibility for the internal audit program
Auditor competence – methodology and sector/discipline
Auditor competence – methodology
Auditor competence – sector/discipline
Selection of people for internal auditors
Quiz: identifying internal ‘auditor qualities’
This face-to-face course incorporates Quizzes, Tests and individual assessments to ensure students’ knowledge and skills are properly evaluated. The majority of the time is given over to these activities.
On successful completion of the course and its quizzes/tests/ individual assessments, students will be presented with their Training Certificate.
EXTENDED QUESTION & ANSWER SESSION
Who should attend
The course is primarily aimed at individuals who are required to conduct conformity, compliance and performance audits internally and at all levels in the supply chain. Participants are not required to have any previous experience of auditing.
The course was originally designed for the UK MoD's supplier auditing teams to ensure a common approach to auditing confomity against a variety of standards and perfomance in terms of delivered quality and on-time in-full delivery.
The course is specifically suited for auditing where -
multiple international quality management system standards and customer-specific QMS requirements are involved
organizations do not necessarily have documented procedures
it is simply required to establish the degree of conformity/compliance with customer-specific requirements
Delegates need to have a basic knowledge of ISO 9001:2015 or other ISO 9001-based standards and/or customer-specific requirements they need to audit.
Attendees use their own copies of relevant international standards during the training course.
Deliverables & benefits
Assessment of learning is achieved through structured exercises and real-world audit scenarios undertaken by the participants. The tutors provide feedback and advisement to ensure that best practice is fully understood in the context of sector-specific industry.
Participants will be -
be better equipped to maintain their organization's compliance with international standards (e.g. ISO 9001, AS9100 series, IATF 16949, AQAP 2110, AQAP 2310, IRIS, etc.)
evaluate supplier quality management systems (even when the supplier has no documented QMS)
be confident in knowing that their audit questions address all important issues - including the organization's Leadership!
identify weaknesses in management system performance (e.g. quality and delivery), process-level effectiveness, supplier Q & D, and top management commitment
identify risks and opportunities within the QMS including the supply chain
be able to accrue IRCA & IAQG CPD points because of the highly structured nature of this course
All students successfully completing the 2-day course will receive an individual training certificate containing the TEC's internationally-recognized logo.
The organization will -
be confident that their auditors are empowered to undertake effective internal (and supplier) audits
know that the outcomes of the audits will meet the expectations of all industrial sectors and CBs (Certification Bodies)
be able to assess both conformity to requirements and effectiveness of operational processes