As9100d 2016 Latc Qi PDF

Page 1 of 204
Quality Management System Lead Auditor

Course AS 9100 D:2016
The Course Based on the Requirements of AS9100 Rev D and AS9101 Rev F
and AS 9104 F:2016
Page 2 of 204
Course Introduction
Welcome
We QI is very glade to introduce this 5
days Lead Auditor Training Course. QI is
one of the leading & fast growing
Consultation & Training bodies in Egypt.
QI operates as a Consultation & Training
Body organized according to NQI and
International ISO 17024:2016 in Egypt
and across the globe.
Page 3 of 204
Introduction About QI
• QI is the Quality Institution for Engineering and Management
Consultancy
• Established on 2012 , fast growing Egyptian Consultation and
training firm
• Long term Partnership with Famous organizations such as:
– R&R IRCA partner
– PECB IAS accredited organization for ISO 17024
• Conduct training and Consultation on many management
systems.
Page 4 of 204
QI Clients
Page 5 of 204
Training
Page 6 of 204
Training
Page 7 of 204
Training
Page 8 of 204
Learning Objectives
 Briefly describe what students will know and be able to
do by the end of the course.
On completion successful students will have the
knowledge and skills to:
 Explain the purpose of a quality management

system, of quality management systems standards, of
management system audit, of third party certification and
the business benefits of improved performance of the
quality management system.
Page 9 of 204
Course Assessment
• Course Assessment
The outputs of the exercises are a part of the formal continuous assessment and will
therefore be marked. In order to pass the course a delegate must pass the continual
assessment and the written examination as well.
• Continual Assessment
Delegates will be assessed throughout the course. The outputs of the exercises are a
part of the formal continual assessment and will therefore be marked. Although the
exercises are group exercises individual score to the delegate will be based on their
overall participation, involvement in the relevant chapter presentation and in the
exercise.
Page 10 of 204
Final Exam
Delegates will have to write the written examination on Day 5 of the
course. A total of 2 hours will be available for the Examination.
 There are 4 sections to the exam:
 Section 1 (10 marks)
The pass mark is 70% and delegates are expected to achieve at least
50% in each section.
Page 11 of 204
Complaints
• All delegates have the right to make a complaint or an appeal. The delegates
will be provided with the process for the same upon request.
• QMS Standard
The delegates will be provided with the copies of AS 9100 D:2016 standard for
reference during the course.
• Delegates Introduction
The course introduction is next followed by Delegate introduction. The delegates

are expected to introduce themselves about their Academic Background,
Technical Knowledge / Career experiences.
Page 12 of 204
Auditor AS9100D Scheme

• The scheme is intended for:
• Quality auditors, e.g. those employed by third party
certification bodies / registrars, or by purchasing
organizations
• Quality practitioners, e.g. quality consultants, quality
managers and other quality personnel
• Employees conducting quality management system
audits within their own organization i.e. Internal
Standards
Page 13 of 204

and AS 9104 F:2016
Page 14 of 204
PURPOSE, BENEFITS & PRINCIPLES OF QMS

1. Quality Management System
A Quality Management System (QMS)

is a set of policies, processes and
procedures required for planning and
execution (production / development
/ service) in the core business area of
an organization.
Page 15 of 204
What is AS 9100 REV D?

AS 9100 | AS 9100 Rev D | AS9100D.
Standard for organizations in the Aerospace industry.
Aviation, Space & Defense products & services” The
IAQG (the International Aerospace Quality Group)
created criteria to follow by any organization that has
set a quality management system.
Page 16 of 204
What is AS 9110 REV C?

Organizations whose primary business is providing
maintenance or continuing airworthiness management
services for civil or military aviation articles and products;
and original equipment manufacturers with maintenance,
repair, and overhaul operations that are operated
autonomously, or that are substantially different from
their production operations; should use the IAQG-
developed 9110 standard
Page 17 of 204
What is AS 9120 REV B?

Organizations that procure parts, materials, and
assemblies and resells these products to a customer in
the aviation, space, and defense industry should use
the IAQG-developed 9120 standard (see Bibliography).
This includes organizations that procure products and
split them into smaller quantities, as well as those
that coordinate a customer or regulatory controlled
process on the product.
Page 18 of 204

2. Evolution of AS9100 – Evolution of Standards
Page 19 of 204
Organizational and Strategic Context

 The IAQG is an international non-profit
association under the Belgian law with office
registered in Brussels (Belgium).
 The IAQG is a cooperative organization within
the aerospace & defense industry comprised of
3 sectors (Americas - AAQG, Asia/Pacific -
APAQG and Europe - EAQG).
 The IAQG membership is comprised of three
global Sectors:
 AAQG – Americas Aerospace Quality Group– North, Central
& South America;
 APAQG - Asia-Pacific Aerospace Quality Group - Asia and
Oceania ;
 EAQG – European Aerospace Quality Group - Europe, Middle
East, Russia & Africa;
Page 20 of 204
Purpose of The IAQG

 Promotes a quality culture
 Establishes and maintains harmonized Quality Management System (QMS)
standards
 Delivers the internationally recognized Industry Controlled Other Party
Certification system
 Provides measurable benefits to Stakeholders, Customers and Suppliers
 Collects and offers best practices, processes, training and harmonized
requirements
 Promotes cooperation between international aviation, space and defense
companies
 Maintains relationships with key industry stakeholders, regulatory and
governmental agencies.
Page 21 of 204
IAQG Governance
The IAQG General Assembly sets the
policy, purpose and objectives of the
organization and drives initiatives to
meet the goals and objectives of the
organization. There are twenty-seven
Full Members:
 Ten from the Americas
 Ten from Europe
 Seven from Asia-Pacific
Page 22 of 204
Membership (Companies) EUROPE

 PFW
AMERICAS ASIA-PACIFIC EUROPE
 ATK  Aero Engine Corporation of China (AECC)  Airbus  RAFAEL
 Ball Aerospace
 Boeing  AIDC (Aerospace Industrial Development Corp.)  ArianeGroup  Rolls-Royce
 Bombardier Aerospace  AVIC  BAE Systems  Russian Helicopters
 Embraer
 COMAC  Dassault Aviation
 GE Aviation  Saab
 Goodrich Corporation  EGAT (Evergreen Aviation Technologies Corporation)
 ELBIT Systems
 Gulfstream  FACC  SAFRAN
 Honeywell Engines and Systems  Hindustan Aeronautics Limited
 Lockheed Martin Corporation  GKN Aerospace  Saudi Arabian
 Moog
 IHI Co. Ltd.
Engine Systems Military Industries
 Northrop Grumman  Indonesian Aerospace  Hensoldt (SAMI)
 Parker Aerospace  KAI (Korea Aerospace Industries)  Israel Aerospace  Sonaca
 PCC Aero structures
 Raytheon  Kawasaki Heavy Industries, Ltd. Industries  THALES
 Rockwell Collins  Korean Air
 Leonardo Company
 Rolls-Royce  MBDA  Turkish Aerospace
 Spirit Aero systems  Liebherr-Singapore Pte Ltd Industries (TAI)
 Textron  Meggitt
 MHI  UAC (United Aircraft
 Triumph Group  Motor Sich Corporation)
 ShinMaywa
 UTC (United Technologies  MTU Aero Engines
Corporation)  SUBARU  Zodiac Aerospace
Page 23 of 204
Sponsors
The IAQG is sponsored by three existing bodies
AAQG: SAE International (SAE)
APAQG: Society of Japanese Aerospace Companies (SJAC)
EAQG: Aerospace and Defense Industries Association of
Europe (ASD)
Page 24 of 204

3. Purpose of Quality Management System
 Enhancing customer satisfaction

 Analyse customer requirements
 Keep the processes under control
 Continual Improvement
 Consistently fulfill requirements
Page 25 of 204

4. Benefits of Quality Management System
AS 9100
Page 26 of 204
AS9100 BENEFITS
• AS 9100 is an international group effort with a goal of standardizing a Quality
Management System implementation specific to the Aerospace Industry. When a
company is certified to the AS 9100 standard, they can expect these benefits:
AS 9100 improve your internal processes to maintain high-end quality and achieve
customer expectations
• Implementing the AS9100 standard requires that business processes are
monitored to improve efficiency, make continual improvements and improve
productivity
• Ensure product safety and reliability
• Improve the balance sheet and profitability
• Enhance global marketability
• Standardizes on one audit body and eliminates multiple assessments in the
aviation industry
Page 27 of 204
The IATA Operational Safety Audit (IOSA)

Program is an internationally recognized and accepted
evaluation system designed to assess the operational
management and control systems of an airline. The
IOSA audit creates a standard that is comparable on a
world-wide basis, enabling and maximizing the joint
use of audit reports. This has saved the industry over
6400 redundant audits and continues to lead to
extensive cost-savings for IOSA participating airlines.
Page 28 of 204
What is IOSA and why is it important?

The IOSA certification audit is an internationally recognized and accepted evaluation
system designed to assess the operational management and control systems of an
airline. IOSA uses internationally recognized audit principles and is designed to conduct
audits in a standardized and consistent manner. Airlines are re evaluated every two
years. Registering for IOSA certification and auditing is not mandatory therefore an airline
that does not have IOSA certification may have either failed the IOSA audit or
alternatively chosen not to participate. Small regional airlines generally don’t do the IOSA
audit purely because of the cost to a)have the audit conducted and b) to implement the
likely required changes.
Of course flying with an airline that is IOSA certified doesn’t mean you “wont have a
crash” nor does it mean that an airline without IOSA isn’t safe, but a passenger can have
comfort knowing that an IOSA certified airline does comply with the most stringent of
rules and practices governing aviation safety. Todays results revealed that IOSA certified
airlines had a crash rate three times less than those airlines not on the IOSA registry.
Page 29 of 204

and AS 9104 F:2016
Page 30 of 204
INTRODUCTION TO AUDITING
1. What is Audit?
Systematic, Independent and documented

process for obtaining “audit evidence” and
evaluating it objectively to determine the
extent to which “audit criteria” are fulfilled.
Page 31 of 204
Type of Audits
2. Internal or First Party Audit
• Companies to evaluate the

effectiveness of their own quality
performance
• To identify deficiencies and
inaccuracies within the system
Page 32 of 204
• 3. External or Second Party Audit
• The Second party audit is generally known as the vendor quality assurance audit
• Objectives
1. Qualification of vendors
2. Customer’s requirement shall audit their vendors
3. Improve their quality system
4. Resolve quality problems / issues
Page 33 of 204
• 4. External Third Party Audit
• Third party audits are conducted by
an independent body (certification
body) and can either be voluntary,
as in the case of a certification
audit, or compulsory, as required
by laws and regulations.
Page 34 of 204
• 5. Stage 1 Audit
• To evaluate the quality system is in compliance with a

standard
 Document review
• 6. Stage 2 Audit
• To evaluate the implementation, including effectiveness, of

the client’s management system.
Page 35 of 204
• 7. Follow-up Audit
– Any major non conformities require

– a follow up audit
• 8. Re-Certification Audit
– The Re-Certification audit includes an onsite audit

 Verify the full management system
 Demonstrate commitment
 Enhance overall performance
 Achievement of the organization’s policy and objectives
Page 36 of 204
• 9. Additional Audits
 An additional full audit
 To verify effective correction and corrective actions
• 10. Surveillance Audit

 Surveillance audits are on-site audits
 Certified management system continues to fulfil
requirements
• 11. Extensions to Scope

 May be conducted in conjunction with a
surveillance audit
Page 37 of 204
• 12. Short-notice Audits
 To investigate complaints
 In response to changes
 As follow up on suspended clients
• 13. Multi-site Audits

 Client’s management system covering
the same activity in various locations
 A sampling programme
Page 38 of 204
• 14. Audit Trails
 Step by step with sequential process from

beginning to the end
 Reviewing again by various cross – references
procedures/Documents
 Forward and backward direction of process
sequence
 Audit follows a trail through the business from
origination to completion.
Page 39 of 204
• 15. Auditing statutory and regulatory
requirements
 The statutory and regulatory requirements
 Auditors need to be aware
 Updating all applicable statutory and regulatory
requirements
Page 40 of 204

and AS 9104 F:2016
Page 41 of 204
ACCREDITATION AND CERTIFICATION

1. Accreditation Body- Definition
• Third-party attestation related to a conformity

assessment body conveying formal demonstration of its
competence to carry out specific conformity assessment
tasks
2. Accreditation Process
Page 42 of 204

Page 43 of 204
Page 44 of 204
Accreditation
Process IAW
AS 9101 F:2016
and AS 9104/1 for
CB(CRB) provide
certification for
AS 9100
AS 9110
AS 9120
Page 45 of 204

3. Certification Body
• The certification body will certify the clients on different

standards make its services accessible to all applicants based
on the requirements of the applicant client
Page 46 of 204
Certification Process
Three steps to complete
Application
Document Review
& Contract
Agreements
Audit and
Certification
Page 47 of 204
Page 48 of 204
Page 49 of 204

• The benefits of AS9100 certification for globally-minded businesses include:
– Operational Efficiency: The focus on process management and improvement

means that implementing AS9100 in your business can help improve your
organization's efficiency. Find new ways to save money by producing more
product at a lower cost.
– Stakeholder Relationships: If you want to improve your company's image in
the eyes of your staff, customers and suppliers, demonstrating compliance
with a respected industry standard is a good place to start.
– Minimize Operational Risk: Risk-based thinking like that required by AS9100
helps your organization develop and implement the best practices for the
aerospace industry, improving process quality and product traceability to help
reduce risk and improve product safety.
Page 50 of 204

– Focus on Customer Satisfaction: Improve your relationships with your
customers by offering products that consistently meet or exceed their
quality expectations and are delivered promptly.
– Improve Business Opportunities: Access a wider range of global
markets by obtaining an internationally recognized certification. Many
aerospace manufacturers refuse to do business with anyone without
an AS9100 certification, so obtaining one gives you access to those big
names while simultaneously improving your marketability.
– Protect Organizational Knowledge: Knowledge is one of the most
important resources to aerospace businesses, so protecting it is key.
Using the requirements and guidance of AS9100, you can better
safeguard your organization from information losses and
simultaneously improve your organization's use of knowledge.
Page 51 of 204

and AS 9104 F:2016
Page 52 of 204
QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH
• Quality Management Principles
• It is a set of fundamental beliefs, norms rules and values

that are accepted as true and can be used as a basis for
quality management.
Page 53 of 204

• Seven Quality Management Principles
a. Customer Focus
b. Leadership
Page 54 of 204
• c. Engagement of People
• d. Process Approach
Page 55 of 204
• e. Improvement
• f. Evidence – based Decision Making

Page 56 of 204
• g. Relationship Management
Page 57 of 204
2. Process Approach
The process approach involves the systematic definition and
management of processes, and their interactions, so as to
achieve the intended results in accordance with the quality
policy and strategic direction of the organization.
a. General
b. What is the process approach?
c. Risk-based thinking, PDCA and the process approach
d. What are the possible benefits?
e. The process approach in ISO 9001:2015
Page 58 of 204

Figure 1 — Schematic representation of the elements of a single
process
Page 59 of 204

Figure 2 — Representation of the structure of this International
Standard in the PDCA cycle
Page 60 of 204

Page 61 of 204

and AS 9104 F:2016
Page 62 of 204
AS 9100 D - TERMINOLOGIES
• Counterfeit Part
– An unauthorized copy, imitation, substitute, or modified part (e.g., material, part,
component), which is knowingly misrepresented as a specified genuine part of an
original or authorized manufacturer. Examples of a counterfeit part can include,
but are not limited to, the false identification of marking or labeling, grade, serial
number, date code, documentation, or performance characteristics.
• Critical Items
– Those items (e.g., functions, parts, software, characteristics, processes) having
significant effect on the provision and use of the products and services; including
safety, performance, form, fit, function, producibility, service life, etc.; that
require specific actions to ensure they are adequately managed. Examples of
critical items include safety critical items, fracture critical items, mission critical
items, key characteristics, etc.
Page 63 of 204
AS 9100 D - TERMINOLOGIES
• Product Safety
– The state in which a product is able to perform to its designed or
intended purpose without causing unacceptable risk of harm to
persons or damage to property.
Page 64 of 204

and AS 9104 F:2016
Page 65 of 204
CONTEXT OF THE ORGANIZATION

1. Understanding the organization and its context
• The organization shall
• Determine external and internal issues
• Monitor and review information about these external and internal issues.
2. Auditing Guidance – Context of the Organization

• Issues can include positive and negative factors
• External context includes
• Internal context includes
Page 66 of 204

2. Auditing Guidance – cont…
• External context includes

 Legal, technological, competitive, market, cultural, social and economic
environments, whether international, national, regional or local
 Relationship with and perceptions / values of external stakeholders.
Page 67 of 204

2. Auditing Guidance – cont…
• Internal context includes
 Policies, objectives and strategies
 Corporate culture
 Governance, objectives and strategies
 Resources
 Information systems, information flows and decision-making
processes.
Page 68 of 204

3. Understanding the needs and expectations of
interested parties

• Determine the interested parties
• Determine the requirements of these interested parties
Page 69 of 204

4. Auditing Guidance – Understanding the needs and expectations of
interested parties
• Specifies requirements for the organization to determine the interested parties
that are relevant to the QMS and the requirements of those interested parties.
Page 70 of 204

5. Determining the scope of the quality management system
• The organization shall consider
• External and Internal Issues
• Requirements of relevant interested parties
• The products and services of the organization
• The scope of the organization ‘s QMS

• Shall be available and be maintained as documented information
• Types of products and services covered
Page 71 of 204

6. Auditing guidance – Determining the scope of the quality management
system
• Organization can review the applicability of requirements due to the size or
complexity of the organization.
• Organization’s activities and the nature of the risks
Page 72 of 204

7. Quality management system and its processes
• The organization shall establish, implement, maintain and continually improve a
QMS.
The organization shall determine:
• The inputs required and the outputs expected from these processes.
• The sequence and interaction of these processes.
• Apply the criteria and methods needed to ensure the effective operation and
control of these processes.
• Resources needed for these processes
Page 73 of 204

7. Quality management system and its processes – cont…
• Assign the responsibilities and authorities
• Address the risks and opportunities
• Evaluate these processes and implement any changes needed
• Improve the processes.

• Maintain documented information to support the operation of its
processes.
• Retain documented information to have confidence that the processes
are being carried out as planned.
Page 74 of 204

• The organization shall establish and maintain documented information
that includes:
 a general description of relevant interested parties (see 4.2 a);
 the scope of the quality management system, including boundaries
and applicability (see 4.3);
 a description of the processes needed for the quality management
system and their application throughout the organization;
 the sequence and interaction of these processes;
 assignment of the responsibilities and authorities for these
processes.
Page 75 of 204

and AS 9104 F:2016
Page 76 of 204
LEADERSHIP
1. Leadership and Commitment
• effectiveness of the QMS
• Ensuring that the quality
• policy and quality objectives
• 2. Auditing Guidance – Top Management
• Evidence of top management’s
• awareness of and commitment
• to quality and organization’s objectives
• and management system.
Page 77 of 204
LEADERSHIP
3. Customer Focus
• Customer and applicable statutory and regulatory requirements are determined.
• The risks and opportunities that can affect conformity of products and services.
• Focus on enhancing customer satisfaction.
• Product and service conformity and on-time delivery performance are measured
and appropriate action is taken if planned results are not, or will not be,
achieved.
Page 78 of 204
LEADERSHIP
4. Developing the quality policy
• Is appropriate to the purpose and context of the organization.
• Provides a framework for setting quality objectives.
• Includes a commitment
• Satisfy applicable requirements
• Continual improvement of the QMS
• Communicating the quality policy
• Be available and be maintained as documented information.
• Be communicated, understood and applied within the organization
• Be available to relevant interested parties.
Page 79 of 204
LEADERSHIP
5. Auditing Guidance – Quality Policy
• Audit methods should include:
• Interviewing top management
• Evaluating, through the records of management review.
• Has effectively “translated” the quality policy into the
local languages.
• Conducting interviews with personnel
• Seeking evidence of effective distribution of the quality
policy.
Page 80 of 204
LEADERSHIP
6. Organizational roles, responsibilities and
authorities
• Ensuring
– Requirements of this international standard
– Delivering their intended outputs
– Promotion of customer focus
– Integrity of the QMS is maintained.
– Reporting on the performance of the QMS
Page 81 of 204
LEADERSHIP
Top management shall appoint a specific member of the organization’s
management, identified as the management representative, who shall have the
responsibility and authority for oversight of the above requirements.
The management representative shall have the organizational freedom and

unrestricted access to top management to resolve quality management issues.
NOTE: The responsibility of a management

representative can include liaison with external
parties on matters relating to the quality
management system.
Page 82 of 204

and AS 9104 F:2016
Page 83 of 204
RISK BASED THINKING & PLANNING

1. Risk Based Thinking
 Risk-based thinking has always been in AS 9100 D – this AS 9100
D:2016 builds it into the whole management system.
 Risk-based thinking is already part of the process approach.
 Risk-based thinking considers both the current situation and the
possibilities for change.
2. Where is risk addressed in AS 9100 D:2016?

• The concept of risk-based thinking is explained in the introduction
of AS 9100 D:2016 as an integral part of the process approach.
Page 84 of 204

• AS 9100 D:2016 uses risk-based thinking in the following
way:
 Clause 4
 Clause 5
 Clause 6
 Clause 7
 Clause 8
 Clause 9
 Clause 10
Page 85 of 204

3. Why use risk based thinking?
4. A Risk Assessment – QMS
a. Introduction
b. AS 9100 D:2016 Requirements
c. Process Management
d. Risk Management
e. Integrating Risk into Process Management
f. Example of Risk in process
g. Turtle Diagram Methodology
h. Identification of major risk in process
Page 86 of 204

• c. Process Management
Figure 1 — Schematic representation of the elements of a single process

Page 87 of 204
• d. Risk Management
Page 88 of 204

• f. Examples of Risk in process
Effectiveness Things are done right
Productivity Employees are doing more tasks
Risk Time Reducing Throughput time
Efficiency Employees are doing tasks
Effectiveness Reducing transaction cost

Page 89 of 204

• g. Turtle Diagram Methodology
Page 90 of 204

• h. Identification of major risk in process
Key process Inputs
Key Process Outputs
Key Process Activities

Major Risk
Key Personnel involved
Process effectiveness measurement
Process Objectives
Page 91 of 204

• i. Process Risk Assessment
Page 92 of 204

• j. Process Risk Assessment Matrix:
Process Risk Assessment
Hazard Undesired Risk Assessment Control
Activity Responsible Due Date
Identified Outcome Likelihood Impact Measure
Page 93 of 204

• l. Risk Management Matrix:
RISK MANAGEMENT
Risk Assessment Potential

Primary
Desired Hazard Undesired Residual Undesired Additional Risk
Action Resources
Outcome Identified Outcome Risk Residual actions Owner
Plan
Likelihood Impact Outcome
Page 94 of 204

4. A Risk Assessment – QMS – Cont.
• i. Process Risk Assessment
• j. Process Risk Assessment Matrix
• K. Risk Management Plan
• l. Risk Management Matrix
• m. Benefits of Risk Assessment
• n. Challenges
5. Planning
• Actions to address risk and opportunities
Page 95 of 204
5. Planning
• Actions to address risk and opportunities
• The organization shall plan:
• actions to address these risks and opportunities
• how to
 integrate and implement the actions into its
QMS processes (see 4.4)
 evaluate the effectiveness of these actions.
Page 96 of 204

5. Planning – Cont.
• Options to address risks can include
• avoiding risk
• taking risk in order to pursue an opportunity
• eliminating the risk source
• changing the likelihood or consequences
• sharing the risk, or
• retaining risk by informed decision.
Page 97 of 204

5. Planning – Cont.
• Opportunities can lead to the
adoption of new practices
• launching new products
• opening new markets
• addressing new clients
• building partnerships
• using new technology and
• other desirable and viable possibilities to address the
organization’s or its customers’ needs
Page 98 of 204
6. Quality objectives and planning to achieve them

• Be consistent with the quality policy
• Be measurable
• Applicable requirements
• Conformity of products and services
• Be monitored and communicated
• Be updated
7. Auditing Guidance – Quality Objectives

Page 99 of 204

8. Planning of changes
• The organization shall consider the
purpose of the changes and their potential
consequences
• integrity of the QMS
• availability of resources
• allocation or reallocation of responsibilities and
authorities
Page 100 of 204

and AS 9104 F:2016
Page 101 of 204
SUPPORT
1. Resources
2. People
Page 102 of 204
SUPPORT
3. Infrastructure
4. Environment for the operation of processes

• A suitable environment can be a combination of human and physical factors, such
as:
• social (e.g. non-discriminatory, calm, non-confrontational);
• psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
• physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).
Page 103 of 204
SUPPORT
5. Monitoring and measuring resources
• a. General
• b. Measurement Traceability
6. Auditing Guidance – Monitoring and Measuring Resources

• The auditors should evaluate the following
• How the organization validates that “the monitoring and measuring equipment” is consistent
with the monitoring and measurement requirements.
• How the organization assures the information validity and the consistency of the results.
• The competence of those responsible for using “the monitoring and measuring equipment”
• The organization shall maintain a register of the monitoring and measuring equipment. The
register shall include the equipment type, unique identification, location, and the calibration or
verification method, frequency, and acceptance criteria.
• Calibration or verification of monitoring and measuring equipment shall be carried out under
suitable environmental conditions (see 7.1.4).
Page 104 of 204
SUPPORT
7. Organizational Knowledge
8. Competence
SUPPORT
Page 105 of 204
9. Awareness
10. Auditing Guidance – Resource management

Page 106 of 204
SUPPORT
11. Communication
12. Auditing Guidance - Communication

Page 107 of 204
SUPPORT
13. Documented Information
• General
• Creating and Updating
• Control of documented information
14. Auditing Guidance – Requirements of Documented Information of

AS 9100 D:2016
• a. Introduction
• b. What is documented information? ‐ Definitions and references
• c. AS 9100 D:2016 Documentation Requirements
• d. Guidance on Clause 7.5 of AS 9100 D:2016
Page 108 of 204

and AS 9104 F:2016
Page 109 of 204
OPERATION
1. Operational planning and control
a. Operational Risk Management
b. Configuration Management
c. Product Safety
d. Prevention of Counterfeit Parts

Page 110 of 204
OPERATION
2. Requirements for products and services
a. Customer communication
b. Determining the requirements related to products and services
c. Review of requirements related to products and services
d. Changes to requirements for products and services
Page 111 of 204
OPERATION
3. Auditing Guidance – Customer communication
Page 112 of 204
OPERATION
4. Design and Development of Products and Services
a. Design and Development Planning
b. Design and Development Inputs
c. Design and Development Controls
 Design and Development Review
 Design and Development Verification
 Design and Development Validation
• d. Design and Development Outputs
e. Control of Design and Development Changes
Page 113 of 204
OPERATION
5. Auditing Guidance – Design and Development
a. Auditing the need for design and development
b. Auditing design and development planning
c. Auditing design and development inputs
d. Auditing the design and development controls
e. Auditing design and development outputs
f. Auditing design and development changes
Page 114 of 204
OPERATION
6. Control of externally provided processes, products and
services
a. General (Doc. Control , Audit , register, actions)

b. Type and extent of control
c. Information for external providers
7. Auditing Guidance - Control of externally provided

processes, products and services
OPERATION
Page 115 of 204
8. Production and Service Provision

a. Control of Production and Service Provision
 Control of Equipment, Tools, and Software Programs
 Validation and Control of Special Processes
 Production Process Verification
b. Identification and traceability
c. Property belonging to customers or external providers
d. Preservation
e. Post-delivery activities
f. Control of changes
9. Release of products and services

• The documented information shall include:
 evidence of conformity with the acceptance criteria
 traceability to the person(s) authorizing the release
Page 116 of 204
OPERATION
10. Control of nonconforming outputs
a. Controlling Nonconforming outputs by one or more of the
following ways:
 correction
 segregation, containment, return or suspension of
provision of products and services
 informing the customer
 obtaining authorization for acceptance under
concession
b. The organization shall retain documented information
that:
 describes the nonconformity;
 describes the actions taken;
 describes any concessions obtained;
 identifies the authority deciding the action in respect
of the nonconformity.
Page 117 of 204

and AS 9104 F:2016
Page 118 of 204
PERFORMANCE EVALUATION & IMPROVMENT

1. Monitoring, Measurement, Analysis and Evaluation
a. General
b. Customer satisfaction
• c. Analysis and evaluation
2. Internal Audit
Page 119 of 204

3. Management Review
a. General
b. Management review inputs
c. Management review outputs
• Auditing Guidance – Management Review
• 4. Improvement
a. General
Page 120 of 204

5. Non conformity and corrective action
6. Continual improvement
Page 121 of 204

7. Auditing Guidance – Continual Improvement
Page 122 of 204

and AS 9104 F:2016
Page 123 of 204
MANAGEMENT OF AUDIT PROGRAMME

An audit programme should be established which can include
audits addressing one or more management system standards
or other requirements, conducted either separately or in
combination (combined audit).
The extent of an audit programme should be based on the size
and nature of the auditee, as well as on the nature,
functionality, complexity, the type
of risks and opportunities, and the level
of maturity of the management system(s) to
be audited.
Page 124 of 204
• In order to understand the context of the auditee, the audit

programme should take into account then auditee’s
 organizational objectives
 relevant external and internal issues
 the needs and expectations of relevant interested parties
 information security and confidentiality requirements

Page 125 of 204

• The audit programme should include information and identify resources to enable the
audits to be conducted effectively and efficiently within the specified time frames.
The information should include
 objectives for the audit programme
 risks and opportunities associated with the audit programme (see 5.3) and the actions to
address them
 scope (extent, boundaries, locations) of each audit within the audit programme
 schedule (number/duration/frequency) of the audits
 audit types, such as internal or external

Page 126 of 204

and AS 9104 F:2016
Page 127 of 204
AUDITOR RESPONSIBILITIES
1. The Roles and Responsibility of the Team Leader
• Ensure the audit scope
• Select the audit team
• Direct the audit team members
• Planning the audit & make effective use of resources
• Represent the audit team
• Manage the audit team
• The preparation of the report

Page 128 of 204
• 2. The Role of the Auditor
• The auditor is responsible to the Lead Auditor for an allocated segment of the audit programme. This includes:
• Communicating audit requirements to the auditee
• Auditing in accordance with the relevant checklists
• W here time permits, examining discovered areas of concern
• Documenting observations
• Recording evidence
• Verifying the effectiveness of the Quality Management system

Page 129 of 204
3. The Role of the Auditee and Audit Client
• Auditee: Organization being audited
• Audit Client: Organization requesting the audit.
a. Before the audit activity begins

b. During the pre-audit visit or through other means of
communication
c. During the Audit
d. Post – Audit
Page 130 of 204
4. Roles & Responsibilities of Guides & Observers
• Guides and observers may accompany the audit team

with approvals from the audit team leader, audit client
and/or auditee, if required. They should not influence
or interfere with the conduct of the audit. If this cannot
be assured, the audit team leader should have the right
to deny observers from being present during certain
audit activities.
Page 131 of 204
7. Audit Principles
• Auditing is characterized by reliance on a number of principles.

These principles should help to make the audit an effective and
reliable tool in support of management policies and controls, by
providing information on which an organization can act in order to
improve its performance. Adherence to these principles is a
prerequisite for providing audit conclusions that are relevant and
sufficient, and for enabling auditors, working independently from
one another, to reach similar conclusions in similar circumstances.
Page 132 of 204
8. IAQG Code of Conduct
It is a condition of certification that you agree to act in accordance
with, and be bound by the following IAQG Code of Conduct:
1. To act in a strictly trustworthy and unbiased manner in relation
to both the organisation to which you are employed, contracted
or otherwise formally engaged (the audit organization) and any
other organisation involved in an audit performed by you or by
personnel under your direct control.
2. To disclose to your employer any relationships you may have
with the organisation to be audited before undertaking any audit
function in respect of that organization.
Page 133 of 204

and AS 9104 F:2016
Page 134 of 204
COMPETENCE & EVALUATION OF AUDITORS

1. Competence & Evaluation Of Auditors
• Confidence in the audit process and the ability to
achieve its objectives depends on the competence of
those individuals who are involved in performing audits,
including auditors and audit team leaders. Competence
should be evaluated regularly through a process that
considers personal behaviour and the ability to apply
the knowledge and skills gained through education,
work experience, auditor training and audit experience.
Page 135 of 204

Page 136 of 204

2 Determining auditor competence
a. General
b. Personal behaviour
c. Knowledge and skills
(i) General
(ii) Generic knowledge and skills of management system auditors
(iii) Discipline and sector-specific competence of auditors
(iv) Generic competence of audit team leader
(v) Knowledge and skills for auditing multiple disciplines
d. Achieving auditor competence
e. Achieving audit team leader competence
Page 137 of 204

3. Establishing auditor evaluation criteria
The criteria should be qualitative (such as having
demonstrated desired behaviour, knowledge or the
performance of the skills, in training or in the
workplace) and quantitative (such as the years of
work experience and education, number of audits
conducted, hours of audit training).
Page 138 of 204

4 . Selecting appropriate auditor evaluation method
• The evaluation should be conducted using two or more of
the methods given in Table 2. In using Table 2, the following
should be noted:
• the methods outlined represent a range of options and may
not apply in all situations
• the various methods outlined may differ in their reliability
• a combination of methods should be used to ensure an
outcome that is objective, consistent, fair and reliable
Page 139 of 204

5 . Conducting auditor evaluation
The information collected about the auditor under

evaluation should be compared against the criteria set in
7.2.3. When an auditor under evaluation who is expected
to participate in the audit programme does not fulfil the
criteria, then additional training, work or audit experience
should be undertaken and a subsequent re-evaluation
should be performed.
Page 140 of 204

6 Maintaining and improving auditor competence
Auditors and audit team leaders should continually
improve their competence. Auditors should maintain their
auditing competence through regular participation in
management system audits and continual professional
development. This may be achieved through means such
as additional work experience, training, private study,
coaching, attendance at meetings, seminars and
conferences or other relevant activities.
Page 141 of 204

and AS 9104 F:2016
PERFORMING AN AUDIT – PRE AUDIT ACTIVITIES Page 142 of 204
PLANNING THE AUDIT – PART I

Typical audit activities may be divided into three
phases
1. Pre-Audit Activities
2. On-site Audit Activities
3. Post Audit Activities

Audit Approaches are linked to several principles that are promoted by the AS9100 series standards.
Each Audit Approach is described by the AS9101 Standard through a list of requirements that auditors
can easily recognize; however, they are presented in a different order than they are in the AS9100 series
standards. These approaches provide for a more effective audit trail than clause-by-clause auditing.
These
approaches focus on several areas, including:
 Customer Focus
 Organizational Leadership
 QMS Performance and Effectiveness
 Process Management
 Special Processes
 Continual Improvement
PERFORMING AN AUDIT – PRE AUDIT ACTIVITIESPage 144 of 204

Pre-Audit Activities
1. Initiating audit
2. Establishing contact with auditee
3. Determining feasibility of audit
PLANNING THE AUDIT – PART II

1. Preparing Audit Activities
a. Performing review of documented information
Audit Sampling plans
b. Audit planning
c. Audit Planning Details
d. Assigning Work to Audit Team
e. Preparing Documented Information for Audit
PERFORMING AN AUDIT – PRE AUDIT ACTIVITIES
Page 146 of 204


Sampling
 establishing the objectives of sampling
 selecting the extent and composition of the
population to be sampled
 selecting a sampling method
 determining the sample
size to be taken

 Judgment-based sampling
 Statistical sampling
Preparing audit work documents
When preparing audit work documents, the audit team should consider
the questions below for each document.
Which audit record will be created by using this work document?
Which audit activity is linked to this particular work document?
Who will be the user of this work document?

Checklists
a. Introduction
b. Purpose
c. Preparation of Checklists
d. Advantages of Checklists
e. Disadvantages of Checklist
f. Essential features of a Process Based Checklist
g. Conclusion
Page 150 of 204

and AS 9104 F:2016
ON-SITE AUDIT ACTIVITIES – CONDUCTING Page 151 of 204
THE AUDIT PART-I

1. Opening Meeting
• Agenda
– Introduction
– Roles of auditor auditee guide observer
– Attendance list
– Audit objective
– Audit scope
– Audit Criteria
– Documentation status
– Agenda plan
– Audit methods
– Risk management
– Communications
THE AUDIT PART-I

• Agenda – Contd…
• Language
• Confirmation to resources and facilities
• Confidentiality
• Safety, security, and emergency considerations
• Reporting method
• Closing meeting
• Acknowledgments
• Complaints or appeals
• Concerns or questions
• Participants
THE AUDIT PART-I

2. Stage – 1 Audit
THE AUDIT PART-I

3. Document Review
Page 155 of 204

and AS 9104 F:2016
THE AUDIT PART-II

1. Stage – 2 Audit
THE AUDIT PART-II

2. Communication during the audit
3. Audit information availability and access
4. Reviewing documented information while conducting
audit
5. Collecting and verifying information
6 Selecting sources of information
7 Visiting the auditee’s location
8 Guidance on conducting Interviews
THE AUDIT PART-II

9. Conducting Interviews
a. The Communication Process
THE AUDIT PART-II

b. Talking
Technique Benefits
Open:  Encourages open discussion
How… Why…. When…. Where… What..  Relaxes auditee
How do you carry out your risk assessments?  Encourages auditee to describe
Closed:  Allows definitive answers to be obtained

Do… Can…  Clarifies ambiguity
Do you always send a copy of the completed risk  Avoids auditee evading questions
assessments to the corporate Health and Safety Team?
Reflective:  Confirms information given previously
You said that….  Allows the auditee to expand
You said that completed risk assessments from contractors  Shows the auditee that the auditor is
do not always get sent to you. How do.. You handle those listening
situations?
THE AUDIT PART-II

b. Talking – Contd..
Technique Benefits
Comparative:  Allows auditor to focus on
Comparing…. specific issues
How do risk assessments produced by teams  Encourages the auditee to open
on site compare with generic risk assessments? up discussion
Hypothetical:  Allows auditor to ask specific
Imagine… What if … questions about situations
What if the risk assessments had been which may not have occurred
reviewed by the manager and approved, but  Encourages auditee to think in a
where not adequate for the job, what steps do wider context
you take?
THE AUDIT PART-II

b. Talking – Contd..
Technique Benefits
Leading:  Confirms understanding
When… You do this then…  Prevents the auditee giving
When you receive the risk assessments from information already given
the contractors, you review them for from the
contractors, you review them for adequacy,
email the result to the purchasing manager
and write a letter to the contractors, what
happens then?
THE AUDIT PART-II

C. Listening
THE AUDIT PART-II

d. Looking
THE AUDIT PART-II

Source of information
Collecting by means of appropriate

sampling
Audit Evidence
Evaluating against Audit Criteria
Audit Findings
Reviewing
Audit Conclusions
Page 165 of 204

and AS 9104 F:2016
Page 166 of 204
AUDIT FINDINGS
1. Determining Audit Findings
2. Recording conformities
3. Recording nonconformities
4. Dealing with findings related to multiple criteria
AUDIT FINDINGS
Page 167 of 204
Conformity is the fulfillment of the requirements

AUDIT FINDINGS
Page 168 of 204
Non Conformity is the non - fulfillment of a requirement.

In order words, a specified requirement is not being met.
This may be categorized as Major, Minor-Non Conformity
AS 9101F:2016 updated to include same

definition as ISO 17021-1:2105
Form 4 is used to report the NCR
AUDIT FINDINGS
Page 169 of 204
a. Minor Nonconformity
Minor Nonconformity would be the failure to conform

to a requirement that in the auditor‘s judgment and
experience is not likely to result in a failure of the
Quality management system..
AUDIT FINDINGS
Page 170 of 204
b. Major Nonconformity
Major Nonconformity would be the total breakdown of the

Quality management system or one of its processes, or the
failure to address a key AS 9100D:2016 requirement.
It would be a nonconformity that in the auditor‘s judgment and

experience would likely result in the system failure or
materially reduce its ability to assure controlled processes.
Page 171 of 204
AUDIT FINDINGS
AUDIT FINDINGS
Page 172 of 204
AUDIT FINDINGS
Page 173 of 204
AUDIT FINDINGS
Page 174 of 204
c. Areas of Concern – Opportunities for Improvement

In some cases, a process may be found conforming, but
still an area of concern. These observations may be
written as Opportunities for Improvement. Since they
are potential problem areas, the organization can consider
taking preventive actions for these observations.
Corrective actions are taken for the reported
nonconformities.
Page 175 of 204

and AS 9104 F:2016
Page 176 of 204
AUDIT CONCLUSIONS AND CLOSING MEETING

Audit Conclusions
Page 177 of 204
1. Closing Meeting
 review the audit findings and any other appropriate
information collected during the audit, against the audit
objectives
 agree on the audit conclusions, taking into account the
uncertainty inherent in the audit process
 prepare recommendations, if specified by the audit plan
 discuss audit follow-up, as applicable
Page 178 of 204
2 Content of audit conclusions

Audit conclusions should address issues such as the following:
the extent of conformity with the audit criteria and robustness of the
management system, including the effectiveness of the management
system in meeting the
intended outcomes, the identification of risks and
effectiveness of actions taken by the auditee to address risks
the effective implementation, maintenance and improvement of the

management system
Page 179 of 204
3 Conducting closing meeting

A closing meeting should be held to present the audit findings
and conclusions.
The closing meeting should be chaired by the audit team leader
and attended by the management of the auditee and include,
as applicable
– those responsible for the functions or processes which have
been audited
– the audit client
– other members of the audit team
Page 180 of 204

and AS 9104 F:2016
POST AUDIT ACTIVITIES – REPORTING AND Page 181 of 204
FOLLOW UP THE AUDIT

1. Preparing the Audit Report
FOLLOW UP THE AUDIT

First Stage Audit Report
Form 1 (Stage 1 Audit Report):
”Key Requirements” replaced with “Confirmation of Requirements” and
now includes a listing of 9100-series clause numbers & titles
FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

Second Stage Audit Report
Form 2 QMS Matrix Report
FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

Second Stage Audit Report
PEPR (Process Effective
Performance Report)
FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

Effectiveness levels
FOLLOW UP THE AUDIT

Audit findings and resultant effectiveness
level NCR(s) have not been issued
NCR(s) have not been issued

Process Results
NCR(s) have been issued

related to Planning
operation
Planning
Operation and Planning Operation NCR(s) have been issued
Process Results
related to Process Results
NCR(s) have been issued related

to Planning operation and
Process Results
FOLLOW UP THE AUDIT

Level 2 here means that the process is
determined and planned activities are
partly or fully realized. The process
however is not delivering the planned
Updated PEM Assessment Levels 1
results and appropriate action is not being
taken. &2
Level 1 means that the

process is not determined
Level 2 here means that the
and planned activities are
process is not determined
not realized. Furthermore
and planned activities are
the process is not delivering
not realized. The process
the planned results and
however is delivering the
appropriate action is not
planned results or if not,
being taken.
appropriate action is being
taken.
FOLLOW UP THE AUDIT

Level 4 here means that the process is
determined and planned activities are fully
realized. The process however is not delivering
Updated PEM Assessment Levels the planned results but appropriate action is
being taken.
3&4
Level 4 here means that the

process is determined but
planned activities are not
fully realized.
The process however is
delivering the planned
Level 3 means that the results.
process is determined but
planned activities are not fully
realized. The process however
is not delivering the planned
results but appropriate action
is being taken.
FOLLOW UP THE AUDIT

Updated PEM Assessment Level
5
Level 5 means that the
process is determined and
planned activities are fully
realized. Furthermore the
process is delivering the
planned results.
FOLLOW UP THE AUDIT

• Second Stage Audit Report
• Form 5
FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

FOLLOW UP THE AUDIT

2. Distributing the Audit Report
FOLLOW UP THE AUDIT

3. Completing the Audit
FOLLOW UP THE AUDIT

4. Conducting Audit Follow-up
Page 203 of 204

and AS 9104 F:2016
Page 204 of 204
Thank you
We hope you enjoyed your course
QI would like you to help us improve by completing the feedback survey

about training.

As9100d 2016 Latc Qi PDF

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

As9100d 2016 Latc Qi PDF

Hochgeladen von

Copyright:

Verfügbare Formate

Page 1 of 204

Quality Management System Lead Auditor

 Explain the purpose of a quality management

The course introduction is next followed by Delegate introduction. The delegates

Auditor AS9100D Scheme

Quality Management System Lead Auditor

PURPOSE, BENEFITS & PRINCIPLES OF QMS

A Quality Management System (QMS)

What is AS 9100 REV D?

What is AS 9110 REV C?

What is AS 9120 REV B?

PURPOSE, BENEFITS & PRINCIPLES OF QMS

Organizational and Strategic Context

Purpose of The IAQG

Membership (Companies) EUROPE

AAQG: SAE International (SAE)

APAQG: Society of Japanese Aerospace Companies (SJAC)

EAQG: Aerospace and Defense Industries Association of

PURPOSE, BENEFITS & PRINCIPLES OF QMS

 Enhancing customer satisfaction

PURPOSE, BENEFITS & PRINCIPLES OF QMS

The IATA Operational Safety Audit (IOSA)

What is IOSA and why is it important?

Quality Management System Lead Auditor

Systematic, Independent and documented

• Companies to evaluate the

• To evaluate the quality system is in compliance with a

• To evaluate the implementation, including effectiveness, of

– Any major non conformities require

– The Re-Certification audit includes an onsite audit

• 10. Surveillance Audit

• 11. Extensions to Scope

• 13. Multi-site Audits

 Step by step with sequential process from

Quality Management System Lead Auditor

ACCREDITATION AND CERTIFICATION

• Third-party attestation related to a conformity

ACCREDITATION AND CERTIFICATION

ACCREDITATION AND CERTIFICATION

ACCREDITATION AND CERTIFICATION

• The certification body will certify the clients on different

ACCREDITATION AND CERTIFICATION

– Operational Efficiency: The focus on process management and improvement

ACCREDITATION AND CERTIFICATION

Quality Management System Lead Auditor

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

• Quality Management Principles

• It is a set of fundamental beliefs, norms rules and values

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

• f. Evidence – based Decision Making

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

QUALITY MANAGEMENT PRINCIPLES, PROCESS APPROACH

Quality Management System Lead Auditor

Quality Management System Lead Auditor

CONTEXT OF THE ORGANIZATION

2. Auditing Guidance – Context of the Organization

CONTEXT OF THE ORGANIZATION

• External context includes