WHAT EVERY EMPLOYEE NEEDS TO KNOW ABOUT THE “NEW” … SAMPLE PAGES.pdf · 2017-10-23 · Rev. D of this International Standard by applying to a registrar and paying a registration

WHAT EVERY EMPLOYEE NEEDS TO KNOW

ABOUT THE “NEW” AEROSPACE

STANDARD - AS9100TM Revision D

A Pocket Guide to the Basics

Written by Harold J. Steudel, Ph.D., P.E.

Steudel & Schultz, LLC2481 Evans Road

McFarland, Wisconsin 53558 Toll-Free Phone: (866) 271-3121 • Fax: (608) 838-8985

Outside the USA Phone: (608) 219-0885 www.isopocketguides.com • E-mail: [email protected]

Copyright © 2000-2017 Harold J. Steudel Any reproduction of any part of this publication without the written

permission of Steudel & Schultz, LLC is strictly prohibited.

AS9100 is a Trademark of SAE

THE NEW AEROSPACE STANDARD

The New Aerospace Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Changes in Rev. D of this Aerospace Standard. . . . . . . . . . . . . . . . . . . . . . . .5

What is the “Process Approach”?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Overview of the seven clauses in the new 9100 Standard. . . . . . . . . . . .9

The Quality Management Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

What does being “registered” mean?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Why would my company want to be registered?. . . . . . . . . . . . . . . . . . . .17

THE DOCUMENTATION SYSTEM

What are the different types of documentation?. . . . . . . . . . . . . . . . . . . 18

How is the documentation system structured?. . . . . . . . . . . . . . . . . . . . . 20

What’s the value of all this documentation?. . . . . . . . . . . . . . . . . . . . . . . . 23

How will the documentation system affect me and my job?. . . . . . . .23

What’s my role in improving the documentation system?. . . . . . . . . . 24

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THE REQUIREMENTS OF THE "NEW" AEROSPACE STANDARD

What does each clause mean?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

A reference section for the clauses of Rev. D of the Aerospace Standard

THE AUDIT PROCESS

What’s the purpose of quality management system audits? . . . . . . . .69

What are auditors looking for? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

How do I prepare for audits? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

How do I answer an auditor’s questions? . . . . . . . . . . . . . . . . . . . . . . . . . . .72

What if we don’t pass the registration audit? . . . . . . . . . . . . . . . . . . . . . . .73

How often are we going to be audited? . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

QUICK REFERENCE GUIDES

The Quality Management Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76

Rev. D of the Aerospace Standard Clauses 4 through 8 . . . . . . . . . . . . .78

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THE NEW AEROSPACE STANDARD

This International Standard is the 2016 revision (Rev, D) of the Aerospace Standard (“AS”) containing requirements for establishing and maintaining a quality management system (QMS). This standard has been revised to follow the new clause structure and requirements of ISO 9001:2015, plus additional requirements for the aviation, space, and defense industries. To assure high levels of customer satisfaction, these types of organizations need to produce, provide, and continually improve, safe and reliable products and services that meet or exceed the requirements of customers and applicable statutory and regulatory requirements. A quality management system is set up by an organization to achieve high levels of customer satisfaction and continual improvement, focusing on common requirements and the reduction of variation and waste (costs) in the supply chain. This is done by; z establishing a quality policy and quality objectives, and z establishing the means to achieve those objectives.

Rather than specify requirements for your final product — what you produce, or your services — what you provide — this International Standardfocuses further “upstream” on the processes — or how you produce or provide quality products and services. This International Standard requires systems for controlling the - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4 © 2000-2017 Harold J. Steudel

THE AS9100CSTANDARD

WHAT EXACTLY IS AS9100C?AS9100C is the 2009 revision of the AerospaceStandard (“AS”) containing requirements forestablishing and maintaining a quality man-agement system (QMS). AS9001C includesthe requirements of ISO 9001:2008 plus additional requirements forthe aviation, space, and defense industries.

To assure high levels of customer satisfaction, these types of organiza-tions need to produce, and continually improve, safe and reliable prod-ucts that meet or exceed the requirements of customers and applicablestatutory and regulatory requirements. A quality management systemis set up by an organization to achieve high levels of customer satisfac-tion and continual improvement, focusing on common requirementsand the reduction of variation and waste in the supply chain. This isdone by

• establishing a quality policy and quality objectives, and• establishing the means to achieve those objectives.

Rather than specify requirements for your final product – what youproduce – AS9100C focuses further “upstream” on the processes – orhow you produce. AS9100C requires documented systems for control-ling the processes you use to develop and produce your products. Thisstandard is based on the idea that there are certain elements everyquality management system must have in place in order to ensure thatsafe, quality products are consistently provided to the customer ontime.

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processes you use to develop and produce your products and/or deliver your services. This standard is based on the idea that there are certain elements every quality management system must have in place in order to ensure that safe, reliable, quality products and services are consistently provided to the customer on time. It’s noteworthy that the requirements in this International Standard are complementary to the customer’s requirement for products and services, as well any applicable statutory and regulatory requirements.

This revision (D) of the International Aerospace Standard was prepared by the International Aerospace Quality Group (IAQG), with representatives from aviation, space, and defense companies in the Americas, Asia/Pacific and Europe. Their goal is to advance initiatives that will make significant improvements in quality and reductions in costs throughout the entire aerospace value stream. This new Aerospace Standard is published by SAE, which provides “uniform requirements, practices and methods for quality assurance in aerospace design, development, production, installation and servicing”. AS9100 is a Trademark of SAE.

CHANGES IN REV. D OF THIS AEROSPACE STANDARDThe changes made to the previous 9100 standard (Rev. C) in developing Revision D, based on ISO 9001:2015 are noteworthy. Some of the major changes are: z A need to enhance the use of the process approach

to consider both risks and opportunities in managing the processes.

z An increased emphasis on achieving performance andvalue.

z Consideration of organizational knowledge as a resourceto be managed.


The AS9100C Standard was prepared by the International AerospaceQuality Group (IAQG), with representatives from companies in theAmericas, Asia/Pacific and Europe. Their goal is to advance initiativesthat will make significant improvements in quality and reductions incosts throughout the entire aerospace value stream. The AS9100CStandard is published by SAE International: TheSociety for Advancing Mobility EngineeringWorldwide. SAE International develops stan-dards for the engineering of powered vehicles,including cars, trucks, boats, aircraft, and others.

WHAT IS THE “PROCESS APPROACH”?According to AS9100C, a process can be considered as a “set of interre-lated or interacting activities which transforms inputs into outputs.” (Seefigure on next page.)

In a company, the output of a process often becomes the input toanother “downstream” process. For example, when a customer order isreceived and reviewed by the Sales Department, the output of the“Sales Order Review Process” may be the generation of a productionorder, which becomes one of the inputs to the production process.

By identifying and managing all “processes” in your company (and theinteractions and handoffs between these processes), your company isembracing the “Process Approach” to management.

What Every Employee Needs to Know About AS9100C 5

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THE QUALITY MANAGEMENT PRINCIPLES Like ISO 9001:2015, this new Aerospace Standard is based on seven principles that are key to the success of your quality management system. These principles are important since they can help your company in achieving its intended performance and quality success.

Principle 1 — Customer Focus Your company needs to focus on its customers (and other interested parties) to understand what the customer needs and expects from your products and services, including price, delivery, warranty, etc., leading to high levels of customer satisfaction.

Principle 2 — LeadershipYour company’s top management needs to:z Establish a quality policy and quality objectives that are

consistent with the mission and strategic direction of your company.

z Provide the human resources, facilities, and work environment needed to provide a quality product and or service.

z Demonstrate a commitment to education and training, continual improvement, and the success of the QMS.

Principle 3 — Engagement of People People at all levels of your company need to be competent, empowered, and be engaged in preventing and solving problems, and recognized for their efforts in achieving performance and success of the QMS.

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WHAT DOES BEING “REGISTERED” MEAN? Companies may be “registered” (or “receive certification”) to Rev. D of this International Standard by applying to a registrar and paying a registration fee. A registrar is a company that will audit your company’s quality management system to see if it is meeting all the necessary requirements.

All companies will be registered to Rev. D of this International (Aerospace) Standard. If certain aspects of this standard do not apply to your company (for example, if your company doesn’t develop its own product designs), your company would exclude those requirements from the scope of its registration, as documented in the Quality Manual (See the next section on “The Documentation System”).

WHAT DOES BEING “REGISTERED” MEAN?Companies may be “registered” (or “receive certification”) to AS9100Cby applying to a registrar and paying a registration fee. A registrar is acompany that will audit your company’s quality management systemto see if it is meeting all the necessary requirements.

If your company doesn’t develop its own product designs, your compa-ny would exclude those requirements from the scope of its registration.

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WHY WOULD MY COMPANY WANT TO BE REGISTERED? A major reason that most companies want to become registered is that their customers are demanding it. Registration of your QMS assures your customers that your company has the ability to provide quality products and/or services on time. Some of the other benefits a company might expect to see include:z Competitive advantages in marketing an improved

“quality” image.z Better performance of internal operations (less scrap /

rework). z Better quality.z Fewer customer audits.z A stronger focus on customer satisfaction and continual

improvement.z Better documentation and company-wide communication.z Reduced costs.

And all of the above changes can lead to higher levels of financial security for the company and its employees.

WHY WOULD MY COMPANYWANT TO BE REGISTERED?A major reason that most companies want to become registered is thattheir customers are demanding it. Registration to AS9100C assuresyour customers that you have a quality management system with theability to produce, and continually improve, safe, reliable products ontime. Some of the other benefits a company might expect to seeinclude:

• Competitive advantages in marketing an improved “quality”image

• Better performance of internal operations (less scrap / rework)• Better quality• Fewer customer audits• A stronger focus on customer satisfaction and continual

improvement• Better company-wide communication• Decreased costs and higher profitability• Better documentation (see “What’s the value of all this docu-

mentation?”)

And all of the abovechanges can lead to high-er levels of financial secu-rity for the company andits employees.

What Every Employee Needs to Know About AS9100C 13


THE DOCUMENTATION

SYSTEMWHAT ARE THE DIFFERENT TYPES OF DOCUMENTATION? It is likely that one of the major changes your company will go through is to review and possibly improve its documentation system. Rev. D of The Aerospace Standard requires that companies have documented information required by this International Standard, and by what they feel is necessary for the effective operation of the QMS.

Rev. D of this International Standard is less prescriptive than the previous editions, and no longer requires that a company have documentation in the structure of a quality manual, quality procedures (and work instructions), and records. Although no longer required, many companies will continue to use this structure since each type of document serves a different and useful purpose.

1. Quality Manual The quality manual describes your company’s quality management system (QMS). This documented information includes the scope, boundaries, and applicability of the QMS, addressing the products and services, and the organization’s approach to meeting customer’s needs. It includes a description of the core processes, how these processes interact and apply to meeting customer’s needs, and the relevant interested parties. The quality manual likewise describes the company’s quality policy and who is responsible and authorized to manage the system of interrelated processes comprising the QMS. The quality manual is typically 30 to 50 pages long and is usually written with the direct involvement of top management and input from all levels of the organization.

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HOW IS THE DOCUMENTATION SYSTEM STRUCTURED? You can visualize the structure of the QMS documentation described above as a pyramid with four levels:

1 ADDRESSES QUALITY POLICY, ORGANIZATIONAL STRUCTURE, MANAGEMENT RESPONSIBILITIES, ETC.

4 CONTAIN EVIDENCE AND CONTROL MECHANISMS TO SHOW COMPLIANCE AND RESULTS

3 DETAIL METHODS AND GUIDELINES ADDRESSING HOW TO PERFORM THE TASK

2 GIVE ACTIVITY “STEPS” AND ASSIGNED RESPONSIBILITIES ADDRESSING WHO DOES WHAT,

WHEN, AND WHAT DOCUMENTATION

LEVEL 1 Quality Manual

LEVEL 2

Quality Procedures

LEVEL 3 Quality Work Instructions

LEVEL 4

Records & Forms

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THE REQUIREMENTS OF THE “NEW”

AEROSPACESTANDARD

WHAT DOES EACH CLAUSE MEAN? The following are short descriptions of each of the major “sub-clauses” of Rev. D of this International Standard. Each section below contains an explanation of the “essence of the clause” (or what it really means) and a list of the departments that are most affected by the clause, followed by some of the more important details of what’s required by each clause.

Remember that some of the requirements may not apply to your company, depending on how the QMS was defined to meet the context and strategic purpose of your company.

Note: The clause numbers start with “4” because the requirement clauses begin in the fourth section of the new Aerospace Standard. The first three clauses cover the standard’s scope, references, and terms and definitions.

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LEADERSHIP CLAUSE

5z Showing leadership and commitment to customer

focus by understanding and meeting your customers’ needs and expectations, as well as any statutory and regulatory requirements that relate to your products and processes (for example, requirements related to safety, emissions, hazardous materials, etc.).

z Measuring the performance of the quality management system (on-time delivery, quality products and services, customer satisfaction, etc.) and taking appropriate action if performance targets are not, or will not be, met.

What Every Employee Needs to Know About 9100 Rev. D 31

CLAUSE

5

LEADERSHIP

x Showing leadership and commitment to

customer focus by understanding and meeting your customers’ needs and expectations, as well as any statutory and regulatory requirements that relate to your products and processes (for example, requirements related to safety, emissions, hazardous materials, etc.).

x Measuring the performance of the quality management system (on-time delivery, quality products and services, customer satisfaction, etc.) and taking appropriate action if performance targets are not, or will not be, met.


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OPERATION CLAUSE

8CLAUSE 8.1 OPERATION PLANNING AND CONTROL

Essence of the clause: Your company must plan its “production” processes to ensure they can be operated consistently and result in a quality product or service.

Who’s most involved: Manufacturing Engineering and Production or Operations Departments.

In planning and controlling its processes, your company needs to address: z Determining specific requirements for the products and

services.z Defining criteria to determine process performance and

for monitoring, inspection and test activities to ensurea quality product and service.

z Determining the resources needed to meet all product and service requirements. (See Clause 7.1)

z Determining and implementing controls over the processes to meet the criteria, including any critical items with key characteristics.

z Determining and implementing any changes needed in the processes.

z Determining the processes and control needed for the use and maintenance of the products and services.


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PERFORMANCEEVALUATION

CLAUSE

9CLAUSE 9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

Essence of the clause: Your company needs to determine how to monitor and measure the performance of the QMS and customer satisfaction, and then evaluate the data and information to determine the need for improvements.

Who’s most involved: Managers in all departments (The Quality Department is often responsible for coordinating these activities.)

9.1.1 General

Your company needs to determine the what, when, and how to monitor and measure the performance of the QMS, and the when and how these results need to be analyzed and evaluated. In essence, your company must perform regular and thorough “check-ups” to identify any problems in adhering to the QMS, and to check if the system is really “working” to provide quality products and services. Records documenting the results of these activities need to be maintained.

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IMPROVEMENT CLAUSE

10Examples of improvement are simple corrections, corrective actions, continual or breakthrough changes, and organizationalchanges.

CLAUSE 10.2 NONCONFORMITY AND CORRECTIVE ACTION

Essence of the clause: When a nonconformity occurs, including a customer complaint, your company needs to take corrective action to eliminate the cause(s) of the nonconformity by making corrections to the QMS.

Who’s most involved: Managers and personnel of almost every department.

Notice the difference between this clause and clause 8.7 (Control of Nonconforming Outputs). Control of nonconforming output is about putting defective product or service right; corrective action is about putting the quality management system right.

In general, the need for corrective action may be triggered by: z Findings from internal or third-party audits.

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WHAT EVERY EMPLOYEE NEEDS TO KNOW ABOUT THE “NEW” … SAMPLE PAGES.pdf · 2017-10-23 · Rev. D of this International Standard by applying to a registrar and paying a registration