SAMPLE ONLY - The Printed Circuit Buyers Guide to AS9100

Transcription

AN EDUCATIONAL SERIES FROM
the printed circuit buyers guide to...
AS9100
by Imagineering
The Printed Circuit Buyers Guide to...
AS9100
Copyright 2016
BR Publishing, Inc.
DBA: I-Connect007.com
PO Box 50
Seaside, OR 97138-0050
I-Connect007.com, the most extensive global source for news and original content serving the printed circuit design, fabrication and assembly/EMS markets.
ISBN: XXX-XXXXXXXXXX
TABLE OF CONTENTS
Chapter | Title
1 | An AS9100 Primer
2 | Quality Management System
3 | Management Responsibility
4 | Resource Management
5 | Product Realization
6 | Measurement, Analysis and Improvement
7 | About Imagineering
MIL/AERO FLAVORED
GRAPHIC GOES HERE
The Printed Circuit Buyers Guide to... AS9100
Chapter 1:
An AS9100 Primer
AS9100 is a quality management standard for the aviation, space,
and defense industries. AS9100C is based on the ISO 9001 standard, and in fact, includes 100% of the requirements of ISO 9001
and includes over 80 additional requirements specific to the aerospace industry. Being registered to AS9100 means being registered
to ISO 9001 by default, however, many companies choose to
maintain both certifications primarily due to this misunderstanding
with their non-aerospace customers. Both standards are organized
in the same way and use the same numbering system. While there
are additional clarifying sections to the standard, the actual requirements of AS9100 are contained in sections 4.0 to 8.0 and will
be the subject of this book. Throughout this book, anytime the
word “standard” is used, it is referring to the AS9100 QMS Standard. Major requirements will appear as bolded, and sub requirements will be italicized.
IAQG
AS9100 was developed by the International Aerospace Quality
Group (IAQG). which was established to improve quality and reduce costs specifically for the aerospace industry. Like ISO, it is a
global organization and is supported by companies throughout the
aviation, space, and defense industries. Currently, IAQG has over
60 active signatories and sponsors including Airbus, BAE Systems,
Bell Aerospace, Bell Helicopter, Boeing, Bombardier Aerospace, GE
Aerospace, Goodrich, Gulfstream, Honeywell, Lockheed Martin,
Northrop Grumman, Raytheon, Rockwell Collins, Rolls-Royce, and
United Technologies. Consequently, AS9100 has broad corporate
support.
What is a QMS?
QMS stands for Quality Management System and is the entirety
of all of the procedures, forms, processes, policies and organizational structure that define how a company does business with the
purpose of meeting their customer’s needs. Quality management
system is a bit of a misnomer; it is actually a Business Management
System because, every function of our organization is governed by
it. At Imagineering, it is how we do business. A QMS integrates all
of the various internal processes within the organization and intends to provide a process approach for project execution.
What is a Process Based Approach?
A Process Based QMS enables the organizations to identify, measure, control and improve the core business processes that will
ultimately lead to improved business performance. AS9100 continues to be consistent with ISO 9001 in that it utilizes the plando-check-act (PDCA) improvement cycle (Figure 1), and continues
Fig. 1: SAMPLE GRAPHIC Plan-do-check-act (PCDA) improvement cycle concept.
to use the process management structure widely used in business
today. A9100, and frankly good business practices, believes that
desired results are achieved more efficiently when activities and
related resources are managed as processes within a coherent
system. In the context of AS9100, the “processes” are the auditable
clauses of the standard, and the current version contains five (5)
major processes (Figure 2):
1. QMS
2. Management Responsibilities
3. Resource Management
4. Product Realization
5. Measurement, Analysis & Improvement
Each of these major processes have sub-clauses that flow up into
them, and since Product Realization covers everything needed
to produce a produce, it is usually broken down into a variety of
sub-processes (Customer Service, Engineering, Purchasing, Production, etc.). The most important input to this cycle is customer
requirements, and the output of the cycle is customer satisfaction
and continual improvement of the quality system and the standard
Fig. 2: SAMPLE GRAPHIC Continuous improvement of QMS concept.
has been organized around this model. Under these 5 processes
there are three clauses that are considered Key Clauses, which
mean auditors always pay particular attention to these during audits. These three key clauses are 4.1Quality Management System:
General Requirements, 7.1 Product Realization: Planning of Realization Processes and 8.1 Measurement, Analysis and Improvement:
Planning. These clauses require companies to take ownership of
their quality management system; decide what processes will make
up the system, and how the system will be monitored, measured
and continually improved.
AS9100 also places a great deal of emphasis on Risk, and strongly
encourages that companies embrace a “risk based thinking” approach to running the business. In the context of AS9100, risk is
defined as:
“An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.”
By definition, risk is inherent in every part of a company’s processes
and AS9100 expects measures to be in place to identify risks and
mitigate them.
The road to Risk Based Thinking typically has three paths:
1. Quoting
2. Up front engineering
3. pFMEAs
In Chapter 2 we will start with the first requirement of the standard, General Requirements for the QMS.
Chapter 2:
Quality Management
System
Section 4.0 outlines the general requirements for the QMS, and
is specific in that the QMS must address customer, statutory and
regulatory requirements in addition to AS9100. The focus here is
on defining the company’s processes and the metrics for each of
them. Again, this refers to the processes defined in Figure X, not
the functional processes that are used to create a product or service. There are a number of steps that need to be taken to comply
with this section:
• Identify the processes needed for the QMS
• Determine the sequence and interaction of these processes
• Determine criteria and methods required to ensure the
effective operation and control of these processes
• Ensure the availability of information necessary to support
the operation and monitoring of these processes
Measure, monitor and analyze these processes and implement
action necessary to achieve planned results and continual improvement. There are two key requirements in Section 4.0; Documentation and Control of Records.
Documentation
This requirement defines the minimum documents that are needed
to comply with AS9100. The key take aways here are that documents need to be controlled and approved, all personnel need to
have access to the current approved documents, and they must be
legible. Personnel access can be accomplished via either electronic
or paper documents, as long as they are available at the point of
use and cannot be modified.
The four documentation requirements are:
1. A Statement of Quality and Quality Objectives
2. A Quality Manual
3. Documented Procedures and Records required by AS9100
4. Documents needed by the company to effectively run the
business
It is important to note that anytime the standard states “documented procedure”, it is required to have a documented process to
address the requirement. It is also very important to understand
that “procedure” does not necessarily mean a typical text based
SOP (Standard Operating Procedure); a procedure can be a work
instruction, process flow chart, pictorial instruction, video or any
other media.
The six (6) “documented procedures” required by the standard are:
1. Control of Documents
2. Control of Records
3. Control of Monitoring & Measuring Equipment (Calibration)
4. Internal Audits
5. Control of Nonconforming Product
6. Corrective and Preventive Action
It is important to note that while these six documents are the
only ones absolutely required by the standard, you can certainly
take the minimalist approach but have to be aware of the earlier
discussed 4th documentation requirement that states “Documents needed by the company to effectively run the business”.
This is where other functional procedures may be required for the
business such as purchasing and work instructions for production
processes.
The Quality Manual is the top-level document of the QMS and
every other element flows down from, and supports, the quality
manual. The key requirements of the quality manual are to describe the scope of the QMS, outline the documents included in
the QMS, and to define the QMS processes and their interaction
(Figure X). This section also requires the control of any document
included in the QMS; meaning identification, changes and distribution needs to be controlled. The last part of Section 4.0 talks about
Control of Records, or specifically quality records. A quality record
is any form, checklist, etc. that includes information and data that
has been entered on it during the creation of your product. Logs,
inspection reports and travelers/routers are all examples of quality
records. The standard requires the definition of control, storage
and retention times for the QMS documentation. This requirement
also mandates that a company flow down this requirement to the
company’s suppliers, and the common sense approach that Imagineering has taken is to require our suppliers to match our retention
times at a minimum.
Chapter 3 will continue with the second requirement of the standard, Management Responsibility
MIL/AERO FLAVORED
GRAPHIC GOES HERE
Chapter 3:
Management
Responsibility
Section 5.0 speaks to the expectations of “top management” to
fully support, implement and continually improve the QMS. Top
management is loosely defined as the group of senior company
executives that are charged with managing the direction of the
company, and is typically made up of the Management Review
members (more on this later). From a high level, top management
is responsible for seeing that customer requirements are determined and fulfilled, and also have the specific responsibility for
measuring product conformity and on-time delivery, taking appropriate remedial actions when required. There is a trend in all QMS
standards to place more emphasis on the company to support the
quality system, starting with top management.
AS9100 expects top management to ensure this by:
• Developing a Quality Policy
• Establishing Quality Objectives
• Holding Management Reviews
• Providing required Resources (people, equipment, technology, etc.)
• Communicating to all employees the importance of meet-
ing customer and other requirements
Management responsibility has always been implied with QMS
standards, but AS9100 places more emphasis on this requirement,
and total top management involvement is not optional!
There is a specific expectation that top management place the
focus of the organization on the customer. This includes communicating to the workforce that every activity should begin with
the endgame of enhancing customer satisfaction. That is why the
standard requires that product conformity and on-time delivery be
measured and actively managed, typically as quality objectives.
The Quality Policy sets the direction and defines the commitment
of the company to the QMS. The structure and content of the
quality policy is up to the organization, but it does require specific
verbiage to address two areas: 1. A commitment to comply with
requirements, and 2. Continually improve the effectiveness of the
QMS. Quality Objectives need to be measureable, appropriate to
the business and consistent with the Quality Policy. Objectives
should include a description of who is responsible, what is the target, and when is it planned to be achieved. Additionally, progress
must be monitored and objectives must be set for relevant processes (again, see Figure X). As mentioned earlier, two of the quality objectives should be product conformity and on-time delivery.
Planning is a very confusing requirement to many companies, but
in the context of AS9100, is specific to planning for the maintenance and improvement of the QMS. The basic function of planning is simply to meet customer requirements through the processes you have put in place to manufacture your product or service.
Quality objectives are part of planning as they relate to product
conformity and are measureable. The other side of planning is
the planning of changes: specifically how the company manages
changes in documents, processes, product and technology.
Responsibility, Authority and Communication is just like it sounds;
ensuring that top management define the responsibilities and
authority for key positions and communicate this throughout the
company. The standard requires that responsibilities, authorities
and their interrelations within the company must be defined and
communicated, and a common tool for this is a simple organizational chart and/or job descriptions.
The Management Representative is the person directly responsible
for the overall QMS, and is typically the top quality executive in
the company. There are two key requirements here, 1. This position
must be officially “appointed” by top management, usually through
the management review process and documented in the meeting
minutes, and 2. This position must have organizational freedom
and unrestricted access to top management. The management
representative is responsible to ensure the quality system is established and maintained, and communicate to management on
the status of the quality system. The management rep must also
communicate awareness of customer requirements throughout the
organization.
The standard recognizes that effective QMS activities cannot happen in a vacuum, so there is an Internal Communication requirement for top management to ensure critical information about
the QMS is flowed down to all employees. This can be addressed
through a variety of mediums, including all-hands meetings, signage, visual management boards, and company-wide flat screen
monitors.
Management Review is the final requirement in Section 5.0 for top
management and calls for the regular review of the QMS to ensure
it remains effective, appropriate for the business and is continually
improved. Remember one of the three key clauses discussed earlier
is 8.1, which states that organizations must plan and implement
measurement and monitoring activities. Those planned measurement and monitoring activities provide the data to analyze and
review at management review, formally called “Analysis of Data”.
Any topic can be included in management reviews, but AS9100
specifies certain topics that need to be included, which are called
“Inputs”.
The seven mandated Inputs are:
1. Results of audits
a. Internal, customer and registrar
2. Customer feedback
3. Scorecards, complaints/compliments, Process performance &
product conformity
a. Scrap and RMA trends
4. Corrective and preventive actions
a. Status and trends
5. Follow-up from prior management reviews
a. Open action items
6. QMS changes
a. New documents/processes
7. Improvement recommendations for the QMS
a. Structure, people, technology, system
The standard also specifies three minimum “Outputs” from the
management review, which refer to any decisions and/or actions
resulting from the review of the Inputs.
The three mandated Outputs are:
1. Improvements to the QMS and processes
2. Improvement to product needed to meet customer requirements
3. Additional resources needed
If no decisions or actions for any of these outputs were assigned,
then a simple statement to this effect in the management review
minutes is sufficient. However, there is a requirement to document management reviews, including any Action Items that were
assigned as an output. The purpose of the management review
process is to monitor the QMS and make adjustments as needed.
When reviewing the management review requirements, it would
be difficult to argue that these are not just good business practices
for any organization, regardless of the QMS that is employed.
Chapter 4 will continue with the fourth requirement of the standard, Resource Management.
MIL/AERO FLAVORED
GRAPHIC GOES HERE
Chapter 4:
Resource
Management
Section 6.0 concerns how the company provides the appropriate
resources to implement, maintain and improve the QMS, or as
mentioned earlier, the business management system. As with all
of the standard requirements, the focus is on assuring compliance
with customer requirements and customer satisfaction. Specifically, AS9100 states that the organization must identify and make
available the resources needed to 1. Implement and improve the
processes of the quality management system, and 2. Address customer satisfaction.
Resources are commonly thought of as human resources, but in
fact refer to any type of resource, including people, equipment,
buildings, equipment and even information technology. Another
part of management’s responsibility is to continuously assess the
company’s resource needs, and react when appropriate. In the context of the AS9100 standard, it simply means providing employees
with all of the tools needed to effectively manage the QMS, and
the business. Regardless of your quality system certifications, most
companies are informally complying with most of these requirements, as they are just common sense Business 101 activities. The
standard breaks down Resources into three (3) major requirements;
Competency, Training & Awareness (a sub requirement under Human Resources), Infrastructure and Work Environment.
Competency, Training & Awareness
The overriding intent of Resources is that companies must assign
competent personnel, meaning that you need to identify what
the requirements are for each position. The premise of this section is that conformity to customer specifications, and by default
customer satisfaction, is directly impacted by how well the workforce is trained. We at Imagineering believe that an honest, deep
dive evaluation of almost any nonconformity in a company can be
traced back to training in some fashion. An employee performing
a manufacturing task incorrectly, not following a procedure, skipping a check off on a form, or misinterpreting a customer technical
requirement are all training issues that can be eliminated with a
robust training and competency program. The key to this requirement is not only the training aspect, but also the competency
portion. Most companies have some type of training program, but
most either do a mediocre job of the training itself, or do not take
it to the next level and make sure that the training was effective.
There are five (5) requirements under this clause:
1. Identification of Required Competence
2. Provision of Training
3. Evaluation of Training Effectiveness
4. Awareness
5. Training Records
Identification of Required Competence
This is basically a training needs assessment; in other words, determining what training each employee needs to perform the task
they are being asked to do. This starts with the interview process
to assess whether an applicant has the required background, education or experience to fill a particular job opening. Competence
identification for existing employees includes both a variety of
standard training that every employee must go through, and training specific to each employee’s functional position. Examples of
standard training would be orientation, safety, and quality policy &
QMS awareness. Functional training would be any procedure, work
instruction, form or equipment instruction specific to a job description or company position.
Provision of Training
Once training needs have been identified, the next expectation
is that the company performs the training that has been identified for each employee. Training can take a number of shapes and
forms, including the following:
• OTJ: On-the-job training means assigning a trained mentor
to a new (to the operation) employee to slowly train them
to the task with full-time instruction and oversight by the
mentor. This is a hands-on, practical application training
that often follows classroom training.
• Classroom: Formally sitting down with an employee(s) in a
classroom setting to review a procedure, work instruction
or other document and often involves a line-by-line review
of the subject matter.
• Read & Understand: This is basically a self-training methodology that can take the form of an employee viewing
a presentation or reading a document on their own. The
premise is that the material is self-explanatory and can be
understood without any instruction.
• 3rd Party: This is training done by an outside entity that can
be performed either in-house or externally. Examples in-
clude certification training, seminars, workshops and customer provided training.
Training programs typically use a combination of all four training
types in their internal program.
Evaluation of Training Effectiveness
Once training has been performed, this section requires the company to evaluate the effectiveness of the training. This means
verifying that employees not only understood the training, but that
they can satisfactorily perform the task that they were trained to.
As this is an ongoing activity, there are many ways to verify training effectiveness quantitatively, such as quizzes and tests, employee performance reviews and scrap and rework reporting. Training
effectiveness can also be evaluated qualitatively by a supervisor or
trained operator signing off on a newly trained employee’s competency at the task. There are also certain operations that require
performance-based verification that can only be verified by evaluating employee output, such as welding.
Awareness
This requirement is very specific in that it requires the company to
assure that each employee is aware of the relevance and importance of their job, and how their job contributes to the company
achieving the quality objectives.
Training Records
As with everything in AS9100, documented evidence is required to
prove the education, training, skills and experience of employees to
meet the competence, training and awareness requirement. Training records can be paper or electronic, but must be documented
and readily available in an employee-training file. Education, skills
and experience can normally be found on either the employee’s
resume or job application, which should be included in the employee-training file. There also needs to be a training record for every
training received by each employee, both internal and 3rd party.
There are plenty of software training programs available, but a
paper system also works just fine.
Infrastructure
The standard requires companies to identify, provide and maintain
the facilities it needs for conformity of product, including: building workspace and associated facilities, equipment, hardware and
software, and support services like transportation, communication
or information systems. A major component of infrastructure is the
maintenance (facilities) program, including both preventive maintenance (PM) and unscheduled maintenance. The key to this requirement is determining the regular PM requirements for each piece
of equipment, and establishing a process to manage unscheduled
maintenance. The facilities and support services portions can be
handled through the facilities function and/or through management review.
Work Environment
This clause is often managed through a company’s safety program,
and the focus here is to achieve product conformance as it relates
to the conditions under which work is performed. Physical factors
such as temperature, noise, lighting, humidity or weather, and
ergonomics are the primary drivers. Things like personal protective
equipment (PPE) like safety glasses and hearing protection also
falls under work environment.
MIL/AERO FLAVORED
GRAPHIC GOES HERE
Chapter 5:
Product Realization
Waiting for content for this section...
MIL/AERO FLAVORED
GRAPHIC GOES HERE
Chapter 6:
Measurement,
Analysis and
Improvement
Waiting for content for this section...
MIL/AERO FLAVORED
GRAPHIC GOES HERE
Chapter 7:
About Imagineering
Award-Winning Family Based Culture
Imagineering was founded as a family business in 1985, and has
remained true to this mission to this day. Relying heavily on family expertise, the company has succeeded by recognizing industry
needs and reacting to serve these needs. Ramzan Dhanji founded Imagineering, Inc. as a photo-plotting business to the printed
circuit board (PCB) industry, quickly becoming one of the most
successful photo-plot tooling services in the business by placing an
overwhelming focus on customer satisfaction and innovation. Current senior management draws heavily from the family, including
President and CFO Pravin Dhanji, CEO Khurrum Dhanji and COO
Sulaiman Roy, and Accounting Manager Lana Matushkina (any others to be added here?). The family values of loyalty, integrity and
relentless customer service have been passed down from Ramzan
to his family and makes up the company culture that drives the
day-to-day operations. The management team spends a lot of time
assuring that every employee embodies these values in everything
they do. Imagineering is extremely active in the community and
industry, winning numerous awards including the Illinois Family
Business of the Year Award.
Customer Relationship Management
One of the ways Imagineering has been able to not only survive,
but also thrive through the numerous economic swings and industry downturns for over 30 years has been their ability to stay one
step ahead of their customer’s needs. Early on, senior management
at Imagineering recognized the importance of developing close,
personal relationships with their customers, and that the key to
their success would be the ability to anticipate customer needs and
the flexibility to react quickly. We have developed a very unique
and effective method of accomplishing this; we actually listen to
our customers! Imagineering’s goal was to cultivate more than
just the typical supplier-customer transactional relationship; we
wanted to be an extension of our customer’s internal engineering
department.
Quick-turn PCB Sourcing from Asia
This customer-centric model drove the next Imagineering innovation in 1987, when Dhanji recognized a need with Imagineering’s
customers for quality, quick-turn raw PCBs, the next logical step
after providing the tooling. Staying true to their business model,
Imagineering strategically decided to focus on providing their customers with a quick-turn solution for proof-of-design, proto-type
and NPI (new product introduction) PCBs, separating Imagineering
from the hundreds of other PCB fabricators supplying production
volume product. Dhanji’s vision was to do something no other
company was doing, providing their customers with value-added,
cost-competitive PCBs manufactured in Asia and delivered in 5
days. This was where nephew Sulaiman Roy was tapped to turn
this vision into reality; drawing upon his extensive experience running a global company in North Carolina that specialized in sourcing out of Asia for the retail industry.
Value-add
The management team was adamant about adding value to their
customers, and implemented many activities that would further
separate Imagineering from their PCB sourcing competition. Understanding that every PCB fabricator’s engineering group has a
unique method of tooling their product, Imagineering engineers
spend a lot of time with customer engineers to assure that their
tooling will integrate seamlessly with their customer’s processes.
Industry-leading quick-turn lead-times out of Asia is a direct result of the quality partners chosen for Imagineering’s supply chain.
While many of Imagineering’s competition (and OEM customers)
have never set foot in the factories of the companies supplying
PCBs, Imagineering will not qualify a supplier until surveys, qualification builds and a physical onsite plant visit have been executed.
Imagineering develops the same close personal relationships with
their supply partners as they do with their customers. Another
innovation that sent shockwaves through the industry are Imagineering’s “PCB Specials”; promotional discounts and services that
one might expect from Amazon or big box retailers but unheard of
in the PCB industry.
Quick-turn Turnkey Assembly
Imagineering’s continuous focus on customer needs has driven
their latest service offering, quick-turn assembly. Following the
same relentless focus on anticipating customer needs that led to
quick-turn PCBs, Imagineering has developed in-house assembly
capabilities to offer a “one stop shop” to our customers, again concentrating on proof-of-design, proto-type and NPI. Drawing once
again from the family, Khurrum Dhanji was tasked with moving the
company into the assembly business. Khurrum understood that the
typical assembly high volume equipment would not work in Imagineering’s business model and focused on developing an equip-
ment set that would be small and nimble enough to support rapid
changeover of part numbers with minimal setup. The result was
a highly flexible assembly operation that supports Imagineering’s
quick-turn PCB offering.
AS9100
Imagineering’s relentless focus on the customer has let them to
the decision to upgrade their current ISO 9001 quality management system (QMS) to the Aerospace AS9100 version. Customer
pressure (or demand) is typically the driving factor for most companies to pursue the stringent, and daunting AS9100 certification,
but this is not the case with Imagineering. Once again, Imagineering is differentiating themselves as this decision was solely based
on the desire to improve the company, and their service to their
customers.
Imagineering’s intent with this book is to educate our customers on
AS9100, its benefits, and how this certification makes Imagineering
a better supplier to them.

SAMPLE ONLY - The Printed Circuit Buyers Guide to AS9100

Transcription

Similar documents

For a neutral but informed overview of French Property

The Australian Bureau of Meteorology - approach to QM

Virtual Home Makeover App - Realtor Association of Sarasota and

Bolean Lake Fire - Regional District of North Okanagan

Build your brand through sharing great experiences

TB-CDP02-TX/RX

Router High-Flex Green Efficiency

Thevenin`s and Norton`s Equivalent Circuit

The Beat Goes On - Room 217 Foundation