AS 9100D –UDI -2

Exemplar Global-QM Group Exercises Submission Packet

Members

Members

Group No.

Date

Understanding AS9100D
Group Exercises Submission Packet
Instructions
 Use this packet to submit your work for the QMS Group Exercises.
 Record the names of all group members and the group number on the lines provided above.

Attachments
 Context Worksheet (Group Exercise 1)
 Expectations Worksheet (Group Exercise 2)
 Audit Scenarios – Clauses 4-6 (Group Exercise 3)
 Audit Scenarios – Clauses 7-8 (Group Exercise 4)
 Audit Scenarios – Clauses 9-10 (Group Exercise 5)

Understanding the Requirements of AS9100D R6 11.19

 CONTEXT
WORKSHEET

Categories Releva Issu Issu Issu Issu

nt es es es es
social
cultural
political
legal
regulatory
financial
technological
Exter
nal

economic
natural environment
competition‐int'l
competition‐nat'l
competition‐local
trends
stakeholder
relationships
governance
organization structure
roles and authorities
policies
objectives
strategies
capital resource
time resource
people resource
Intern

technological
al

IT
information flows
decision making
processes
stakeholder (internal)
culture
standards
guidelines
models adopted by the
org
contractual relationships
 EXPECTATIONS WORKSHEET

# Expectations IP Source

10

11

12

13

14

15
 Risk and Opportunity
Worksheet
Risk Promis
Objective Failure in Effect of Severit Caus Occurren Recommended Who
= Sev x ed
Meeting Failure y e ce Action
Occ Date
QMS Group Exercise 3: Audit Scenarios – Clauses 4-6 Page 1 of 6

Members

Members

Group No.

Date

Understanding AS9100D
QMS Group Exercise 3: Audit Scenarios
Clauses 4-6

Intent
 Understand the requirements of context, leadership and planning of the QMS.

Instructions
 Analyze the scenario and identify the clause or requirement of AS9100D being tested.
 Determine if the scenario is conforming or nonconforming.
 Identify why. (Do not repeat the standard verbatim.)

Understanding the Requirements of AS9100D R6 11.19

Page 2 of 6 QMS Group Exercise 3: Audit Scenarios – Clauses 4-6

1. Tubbs Products designs and manufactures products for their customers. The design activities are
conducted at Corporate Headquarters and manufacturing is conducted at two plant facilities.
There is a small design group at the plant facilities that handles minor design changes made to
the product. For AS9100D, they have determined their scope to only include the two plant
facilities; product design conducted at headquarters and the small design group at the plant
facilities are not included in the scope.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

2. You completed an internal audit of your company and—after interviewing numerous

people— you discover no one was able to describe the company quality policy or how it applies
to their job.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 3: Audit Scenarios – Clauses 4-6 Page 3 of 6

3. Acme Aero Component Company uses a risk analysis method that includes numerical rankings
to prioritize risk. They have established a numerical threshold. Numerical rankings above the
threshold are addressed with actions to mitigate risk; rankings below the threshold do not require
any mitigation actions. An audit reveals there is no evaluation of the determined threshold value
for effectiveness and the actions taken have not been evaluated for effectiveness.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

4. The organization has a customer complaint from a large customer for chronically not meeting
their 98% on-time delivery performance requirement. The organization’s response is that their
internal target for delivery for all customers is 95%. As such, they consider this customer
delivery requirement to not be a relevant requirement for their quality management system since
AS9100D gives them the authority to determine what is a “relevant requirement”.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

Understanding the Requirements of AS9100D R6 11.19

Page 4 of 6 QMS Group Exercise 3: Audit Scenarios – Clauses 4-6

5. AAC maintains a QMS certified to AS9100D and interviewed their top five customers in the
aerospace and defense segments for customer expectations. “They are our leading customers. I
know it is only 60% of our business, but if I know the aerospace and defense segments’ customer
expectations, then I know our entire customer base. Our other customers are non-aerospace and
distributors.”

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

6. Paulson Machined Products is mainly a “build to print” job shop. They also do simple product
design when requested by the customer. They only have one CAD station in-house to support
product design activities and one engineer who is competent in CAD. Since they want to
demonstrate to customers that they have design capabilities, they have included design in the
scope for the company. However, they have decided to exclude requirements for design and
development of products (8.3) from their QMS since the design work they do is simple.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 3: Audit Scenarios – Clauses 4-6 Page 5 of 6

7. When you ask to be introduced to the Management Representative, the Quality Manager tells
you they eliminated the role because it is no longer required “by the standard.”

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

8. Amber Inc. has set 50 parts per million (PPM) defects as the only objective for quality
improvement. They have set PPM goals for the plant and each of the departments included in the
business plan. No specific timeframe has been set for this objective.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

Understanding the Requirements of AS9100D R6 11.19

Page 6 of 6 QMS Group Exercise 3: Audit Scenarios – Clauses 4-6

9. QMS documentation indicates that changes are managed by the Quality Manager, customer
product design changes are managed by Product Engineering, manufacturing process changes
are managed by Production or Manufacturing Engineering, and changes to commercial
agreements are managed by Sales. The integrity of the QMS is not considered a relevant factor
in any of the methods used to manage changes.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

10. Acme Aero has evidence of a process to monitor and review information only regarding external
issues that could affect the organization’s ability to sustain the growth in sales required in their
business plan.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 4: Audit Scenarios – Clauses 7-8 Page 1 of 7

Members

Members

Group No.

Date

Understanding AS9100D
QMS Group Exercise 4: Audit Scenarios
Clauses 7-8

Intent
 Understand the requirements of support and operation.

Instructions
 Analyze the scenario and identify the clause or requirement of AS9100D being tested.
 Determine if the scenario is conforming or nonconforming.
 Identify why. (Do not repeat the standard verbatim.)

Understanding the Requirements of AS9100D R6 11.19

Page 2 of 7 QMS Group Exercise 4: Audit Scenarios – Clauses 7-8

1. “We use the same new product process for all products. We really do not care if the component
goes into an actuator or a seat recliner. If we have a problem, we typically catch it during
verification. We will make changes to accommodate the customer, but at their cost,” says the
Program Manager for the BSB Bearings & Bushings Company.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

2. Competency in XYZ Corporation is determined based on performance evaluations conducted

annually. Training plans are developed for those employees that do not meet the minimum
requirements defined in their associated job descriptions. It has been determined that after
actions have been taken, employees are not always able to perform to the minimum
requirements. No other evaluations are necessary according to the HR Manager.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 4: Audit Scenarios – Clauses 7-8 Page 3 of 7

3. The organization determines knowledge needs by periodically reviewing customer requirements.

For example, if the customer requires a specific knowledge-based individual to support
communications, planning and design, the organization obtains the appropriate personnel based
on experience, skills and education. No other inputs are considered for determining
organizational knowledge. The organization has three main processes: Painting, Assembly and
Kitting.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

4. The Director of Engineering tell you that, “The customer provides us with prints that we use for
development purposes. We file them in the file room. People can go in and take prints as needed.
We trust our engineers.”

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

Understanding the Requirements of AS9100D R6 11.19

Page 4 of 7 QMS Group Exercise 4: Audit Scenarios – Clauses 7-8

5. A logistics company claims that they have never had a late delivery that impacted a customer.
This is a partially true statement only if measured against the company’s definition of a late
delivery and not the customer’s. There have been multiple customer complaints about late
deliveries because they did not meet customer delivery requirements. This resulted in downtime
for some customers.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

6. The motors, spindles and other products to be assembled were found in unlabeled trays at the
workstation. You are told the packaging in which they were shipped had identification that was
removed and trashed at receiving, but that this wasn’t a concern because “these folks are
experienced and know what the correct parts are,” according to the Assembly Supervisor.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 4: Audit Scenarios – Clauses 7-8 Page 5 of 7

7. Reviewing the customer satisfaction and customer complaint reports, you note that information
regarding deliveries has not been sent to customers in a timely manner resulting in poor delivery
ratings from two customers. Asking about this, you are told that the online system goes down on
a regular basis and when it is down, delivery information cannot be sent.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

8. XYZ Corporation established Electronic Data Interchange (EDI) communication methods with
customers and suppliers. They assigned customer communication responsibilities within the
organization and communicated those avenues to the customer. They established external
communication requirements and methods with their supply base and trained them accordingly.
No other communication methods were needed to be established per the IT Manager.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

Understanding the Requirements of AS9100D R6 11.19

Page 6 of 7 QMS Group Exercise 4: Audit Scenarios – Clauses 7-8

9. The CNC Company uses the following design and development process:

A. The Program Manager assembles a multidisciplinary project team of designers, sales,

purchasing, tooling and production personnel for planning a development project. Planning
for the development of the product design itself is the sole responsibility of the design
group, with no interactions required with other groups or departments during detailed
design activities.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

B. Define detailed design inputs – functional, performance, previous design, reliability and
maintainability issues. Packaging requirements and durability are not considered a
necessary part of the process.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 4: Audit Scenarios – Clauses 7-8 Page 7 of 7

C. They conduct Project Reviews every two weeks during the product design launch cycle.
They conduct risk analysis, check status of the project to planned dates, and review the
cost to budget, along with the design planning requirements in each meeting. They conduct
design reviews, verification, and validation in stages. When you ask them to give you the
records of design review, they produce documents from several meetings where they had
conducted design reviews.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

Understanding the Requirements of AS9100D R6 11.19

QMS Group Exercise 5: Audit Scenarios – Clauses 9-10 Page 1 of 6

Members

Members

Group No.

Date

Understanding AS9100D
QMS Group Exercise 5: Audit Scenarios
Clauses 9-10

Intent
 Understand the requirements of performance evaluation and improvement.

Instructions
 Analyze the scenario and identify the clause or requirement of AS9100D being tested.
 Determine if the scenario is conforming or nonconforming.
 Identify why. (Do not repeat the standard verbatim.)

Understanding the Requirements of AS9100D R6 11.19

Page 2 of 6 QMS Group Exercise 5: Audit Scenarios – Clauses 9-10

1. It is now October, internal audits are—by the organization’s procedure—scheduled at the

beginning of the year based on information from the previous year. Different processes are
supposed to be audited each month during the year. They have only audited the production,
shipping and purchasing departments thus far this year with many findings noted in all three
areas. You also notice that no changes have been made to the schedule during the course of the
year.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

2. Senior management at Aero Parts, Inc. is committed to quality and the quality management
system (QMS). Senior management delegated the responsibility for conducting Management
Review meetings to the Quality Manager, who reports to the President, to conduct regular
Management Review meetings with the Quality Department and communicate the importance of
meeting customer and regulatory requirements to the organization. The Quality Department also
monitors the effectiveness of all support processes throughout the organization.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 5: Audit Scenarios – Clauses 9-10 Page 3 of 6

3. ABC Company reviews the results of product and process measures and there is evidence that
they use this information to trigger corrective action and/or continual improvement
opportunities. They also make assignments in their Management Review meetings to drive the
same activities and review the effectiveness of the actions at subsequent Management Review
meetings. They have evidence of an employee suggestion program that has resulted in cost
savings and quality improvement for the current and last year during the last audit.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

4. The Aero Parts, Inc. manufacturing company monitors and reacts to the following customer
related performance indicators:

 PPMs at customer
 On time delivery to schedule
 QNs and field returns
 Customer notification and report cards
 Results of customer surveys
 Customer scorecards

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

Understanding the Requirements of AS9100D R6 11.19

Page 4 of 6 QMS Group Exercise 5: Audit Scenarios – Clauses 9-10

5. Aero Parts, Inc. controls their realization processes by measuring in-process characteristics.
They have set goals for reduction of process variation. They adjust the process if it goes out of
statistical control, and work in teams to reduce its variation. However, documented
specifications for characteristics and acceptance criteria for the product are not available.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

6. When performing internal audits, you note that there are monthly audits being performed. The
company only maintains the nonconformities that were written during the audits and the
corrective action on file as evidence that the audits were conducted.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D

QMS Group Exercise 5: Audit Scenarios – Clauses 9-10 Page 5 of 6

7. Aero Parts, Inc. uses the following techniques to control their business processes:
“Our objective is to empower employees to control our process. Our employees are highly
trained and skilled. We have been using the same processes for many years now.” No other
evidence is provided.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

8. The company uses micrometers and calipers when building hose assemblies. Measurement of
key characteristics are made, but not recorded. “These are key measurements, for sure, however,
we don’t really like to create mountains of paperwork and data,” says the Program Manager,
“In fact, our operators are so well trained that we don’t need documented work instructions,
which also saves additional paperwork.”

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

Understanding the Requirements of AS9100D R6 11.19

Page 6 of 6 QMS Group Exercise 5: Audit Scenarios – Clauses 9-10

9. Aero Parts, Inc. conducts annual QMS Management Reviews, led by Top Management. The
management team is responsible for conducting the reviews and establishing action plans. The
Meeting Agenda lists the following items for review:

a. Nonconformities and Corrective Actions

b. KPI performance to quality objectives
c. Results of internal and external audits
d. Customer satisfaction
e. Issues concerning external providers and other relevant interested parties
f. Process performance
g. Product and Service Conformity
h. Adequacy of resources required for maintaining the QMS

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

10. Review of the Nonconformity and Corrective Action processes showed that Aero Parts, Inc.
addresses nonconformities when they occur by taking action to control and correct them and
address the impacts of the nonconformities. They also evaluate the need for further action to
ensure it does not occur elsewhere. No other actions are taken.

Please Circle One: Conforming Nonconforming

CLAUSE:

WHY?

R6 11.19 Understanding the Requirements of AS9100D