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Complete Quality Systems Manual Based on ISO 9001:2015 +
AS9100D
Certification Pending
Initial Release Revision A
PETE PACIFIC MACHINEWORKS, LLC 1622 S Washington St
Wichita, KS 67211
Phone: (316) 650-8858 [email protected]
mailto:[email protected]
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TABLE OF CONTENTS
Introduction
......................................................................................................................................
6
About Pete Pacific Machineworks, LLC
.....................................................................................................
7
Quality Manual Distribution Policy:
..........................................................................................................
7
Section 1: Scope
.................................................................................................................................
8
1.1 General
..........................................................................................................................................
8
1.2 Application
..........................................................................................................................................
8
1.3 Quality Policy Statement
....................................................................................................................
8
Section 2: Normative Reference
.......................................................................................................
10
2.1 Quality Management System
References.........................................................................................
10
Section 3: Terms and Definitions
......................................................................................................
11
3.1 Quality Management System Definitions
.........................................................................................
11
3.2 Quality Management System Pete Pacific Acronyms
.......................................................................
12
Section 4: Context of the Organization
.............................................................................................
13
4.1 Understanding the Organization and Its Context
.............................................................................
13
4.2 Understanding the Needs and Expectations of Interested
Parties .................................................. 13
4.3 Determining the Scope of the Quality Management System
........................................................... 13
4.4 Quality Management System and Its Process
..................................................................................
14
Section 5: Leadership
.......................................................................................................................
15
5.1 Leadership and Commitment
...........................................................................................................
15
5.1.1 General
.......................................................................................................................................
15
5.1.2 Customer Focus
.........................................................................................................................
15
5.2 Quality Policy
....................................................................................................................................
16
5.2.1 Establishing the Quality Policy
...................................................................................................
16
5.2.2 Communicating the Quality Policy
.............................................................................................
17
5.3 Organizational roles, Responsibilities, and Authorities
....................................................................
17
5.3.2 Responsibility for Quality
...........................................................................................................
20
5.5.2 Management Representative
........................................................................................................
5.5.3 Customer Representative
..............................................................................................................
5.5.4 Internal Communication
................................................................................................................
Section 6: Planning
..........................................................................................................................
21
6.1 Actions to Address Risks and Opportunities
.....................................................................................
21
6.1.1
........................................................................................................................................................
6.1.2 Pete Pacific plans:
..........................................................................................................................
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6.2 Quality Objectives
.............................................................................................................................
21
6.3 Planning of Changes
..........................................................................................................................
22
Section 7:
Support............................................................................................................................
23
7.1 Resources
..........................................................................................................................................
23
7.1.1 General
.......................................................................................................................................
23
7.1.2 People
........................................................................................................................................
23
7.1.3 Infrastructure
.............................................................................................................................
23
7.1.4 Environment for the Operation of Processes
............................................................................
24
7.1.5 Monitoring and Measuring Resources
.......................................................................................
24
Measurement Traceability
......................................................................................................................
24
7.1.6 Organizational Knowledge
.........................................................................................................
25
7.2 Competence
......................................................................................................................................
25
7.2.1 General
.......................................................................................................................................
25
7.2.2 Training on the job
.....................................................................................................................
26
7.2.3 Employee motivation and empowerment
.................................................................................
26
7.3 Awareness
.........................................................................................................................................
27
7.4 Communication
.................................................................................................................................
27
Documentation Requirements
...............................................................................................................
27
7.5 Documented Information
.................................................................................................................
28
7.5.1 General
.......................................................................................................................................
28
7.5.2 Creating and Updating
...............................................................................................................
29
7.5.3 Control of Documented Information
.........................................................................................
29
Section 8: Operation
........................................................................................................................
30
8.1 Operational Planning and Control
....................................................................................................
30
8.1.1 Operational Risk Management
..................................................................................................
30
8.1.2 Configuration Management
.......................................................................................................
31
8.1.3 Product Safety
............................................................................................................................
31
8.1.4 Prevention of Counterfeit Parts
.................................................................................................
31
8.2 Requirements for Products and Services/Customer-related
Processes and Outsourcing ............... 31
8.2.1 Customer Communication
.........................................................................................................
31
8.2.2 Determination of Requirements Related to the Products and
Services .................................... 32
8.2.3 Review of Requirements Related to the Product
......................................................................
32
8.2.4 Changes to Requirements for Products and Services
................................................................
32
8.3 Design and Development for Products and Services(Not
Applicable/Excluded).............................. 33
8.4 Control of Externally Provided Processes, Products,
Services, and Purchasing ............................... 33
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8.4.1 General
.......................................................................................................................................
33
8.4.2 Type and Extent of Control
........................................................................................................
33
8.4.3 Information for External Providers
............................................................................................
34
8.5 Production and Service Provision
.....................................................................................................
35
8.5.1 Control of Production and Service Provision
.............................................................................
35
8.5.2 Identification and Traceability
...................................................................................................
36
8.5.3 Property Belonging to Customers and External Providers
........................................................ 36
8.5.4 Preservation
...............................................................................................................................
36
8.5.5 Post-Delivery Activities
..............................................................................................................
37
8.5.6 Control of Changes
.....................................................................................................................
37
8.6 Release of Product and Services
.......................................................................................................
38
8.7 Control of Nonconforming Outputs
..................................................................................................
38
Section 9: Performance Evaluation
...................................................................................................
39
9.1 Monitoring and Measurement
.........................................................................................................
39
9.1.1 General
.......................................................................................................................................
39
9.1.2 Customer Satisfaction
................................................................................................................
39
9.1.3 Analysis and Evaluation
.............................................................................................................
39
9.2 Internal Audit
....................................................................................................................................
39
9.2.1 General
.......................................................................................................................................
39
9.2.2 Quality management system audit
............................................................................................
40
9.2.3 Manufacturing process audit
.....................................................................................................
40
9.2.4 Product audit
.............................................................................................................................
40
9.2.5 Internal audit plans
....................................................................................................................
40
9.2.6 Internal auditor qualification
.....................................................................................................
41
9.3 Management Review 2
.....................................................................................................................
41
9.3.1 General
.......................................................................................................................................
41
9.3.2 Management Review Inputs
......................................................................................................
41
9.3.3 Management Review Outputs
...................................................................................................
42
Section 10: Improvement
.................................................................................................................
43
10.1 General
............................................................................................................................................
43
10.2 Nonconformity and corrective action
.............................................................................................
43
10.3 Continual Improvement
..................................................................................................................
44
QUALITY SYSTEMS MANUAL REVISION INDEX
...................................................................................
45
Attachment A
..................................................................................................................................
46
Process Map
............................................................................................................................................
46
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Organization Chart
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Attachment B
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47
Operational Planning and Control
..........................................................................................................
48
Attachment
C...................................................................................................................................
48
Attachment D
..................................................................................................................................
49
Nonconformity Corrective Action Process
..........................................................................................
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INTRODUCTION
Pete Pacific Machineworks, LLC has developed and implemented a
Quality Management System in order to document and continually
improve the company’s best business practices, better understand
and satisfy the requirements and expectations of its customers and
improve the overall performance of the company.
The Quality Management System of Pete Pacific complies with the
intent of the international standard SAE AS-9100 Rev D as well as
the international standard ISO 9001:2015. This system addresses the
development, production, and servicing of the company’s
products.
The manual is divided into 10 sections that correlate to the
Quality Management System sections of SAE AS-9100 – Rev D. Each
section begins with a policy statement expressing Pete Pacific
obligation to implement the basic requirements of the referenced
Quality Management System section. Each policy statement is
followed by specific information pertaining to the procedures that
describe the methods used to implement the necessary
requirements.
This manual describes the Quality Management System, delineates
authorities, interrelationships and responsibilities of the
personnel responsible for performing within the system. The manual
also provides procedures or references for activities comprising
the Quality Management System to ensure compliance to the necessary
requirements of the standard.
This manual is used internally to guide the company’s employees
through the various requirements of the SAE AS-9100 Rev D. standard
and the company’s best business practices. These business practices
are dynamic and maintained in order to ensure customer satisfaction
and continuous improvement.
This manual is also used externally, to introduce our Quality
Management System to our customers and other external organizations
or individuals. The manual is used to familiarize them with the
controls that have been implemented and to assure them that the
integrity of the Quality Management System is maintained and
focused on customer satisfaction and continuous improvement.
XPeter Chan
President/Owner
Signed by: 6e69ffaa-b296-466f-b81f-ad1b83cc9eca
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About Pete Pacific Machineworks, LLC
Pete Pacific Machineworks, formerly known as Pete Pacific
Machine, was established June of 2006 at its initial site in Derby,
KS. It has since been renamed to Pete Pacific Machineworks, LLC and
relocated to its current site in Wichita, KS.
Pete Pacific has been providing precision machining primarily to
customers in the aviation, aerospace and defense industries. With
more than a decade of experience in the machining industry, Pete
Pacific has the expertise to provide exceptional precision
products. We offer customers precision machining services utilizing
the latest CAD/CAM software and machining equipment. Our expertise
and years of experience allows us to offer our customer very
reliable, high-quality products.
We have realized that delivering precision products is only part
of the total process. It is of equal importance that we provide our
customers with precision products on schedule and at a competitive
price.
Quality Manual Distribution Policy:
The QMS documentation, Quality Manual, procedures, process flows
and many of the forms are online documents. The most current
revision of each document is the online version. With the exception
of some hard copy forms in use, all paper copies of the QMS
documents are considered “reference only” and their current
revision level verified before use. Training on how to access the
QMS documentation will be provided to all employees as part of
their employee orientation. Employee training records are kept on
all permanent employees of Pete Pacific Machineworks.
Access to this manual is provided to the customer and/or
regulatory agencies upon request or where appropriate to satisfy
contractual obligation with Pete Pacific or compliance to the
customers internal quality systems.
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SECTION 1: SCOPE
1.1 General The quality manual outlines the policies and
requirements of Pete Pacific
Machineworks’ Quality Management System. This standard includes
ISO 9001:2015 quality management system requirements and specifies
additional aviation, space, and defense industry requirements for
SAE AS9100 Rev D.
It is emphasized that the quality management system requirements
specified in this standard are complementary (not alternative) to
contractual and applicable law and regulatory requirements. If
there is a conflict between the requirements of this standard and
customer or applicable statutory or regulatory requirements, then
the latter shall take precedence.
1.2 Application Pete Pacific Machineworks has determined that
the following requirements are not
applicable to the current operations at this site and are
documented as exclusions:
• Pete Pacific is primarily a machining manufacturing facility.
The main scope of their supply to the customer is to manufacture
from customer furnished specifications, CAD data, and/or drawings.
Design and development Section 8.3 and its sub-clauses, service is
specifically excluded.
• Production and Service Provisions Section 8.5 is excluded.
(Justification for exclusion – As a manufacturer does not provide
service provisions; Production and services are the responsibility
of the customer; Pete Pacific Machineworks only builds product to
customer requirements)
1.3 Quality Policy Statement
“It is the policy of Pete Pacific Machineworks, LLC to provide
products conforming in all respects to the functional quality
requirements specified by our customers, to include all applicable
specifications, procedures, standards, and codes. Conformance to
this standard of quality must be built into each casting in order
to achieve optimum cost and insure scheduling integrity. Pete
Pacific Machineworks is committed to the on-time and error-free
management and delivery of products for aerospace and military
application.
Aiding in the achievement of company objectives, Pete Pacific
Machineworks, LLC established and maintains a comprehensive Quality
Management System based on SAE AS9100 Rev. D and ISO 9001:2015
while acknowledging customers’ specific requirements. Pete Pacific
Machine works, LLC realizes and emphasizes the importance of
continual process improvement of our Quality Management System. The
Quality Management System shall; Establish procedures that
standardize processes and minimize variation; Engineer
solutions
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that eliminate the potential for defects. Drive employee
accountability for process and product produced. The established
program for the assurance of quality at Pete Pacific, LLC has been
recorded in the company Quality Assurance Manual. No deviation from
the scope of this manual is permitted.
Quality will be the cornerstone of our reputation, our
productivity, and our continued growth in a highly competitive
marketplace. We the employees of Pete Pacific, are responsible for
the quality of everything we do. We will only accept, work on, or
forward any items that meet the standards of Pete Pacific. We are
committed to fulfill our customer’s expectations and will do
everything in our power to work with the personnel, customers, and
suppliers of Pete Pacific to ensure that all standards are
consistently met and improved.”
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SECTION 2: NORMATIVE REFERENCE
2.1 Quality Management System References
The following documents in part or whole, are normatively
referenced or used in the preparation of this document and are
indispensable for its application. For dated references, only the
edition cited shall apply.
• International Standard ISO 9001:2015(E) Quality Management
Systems Requirements
• Pete Pacific Machine Quality Manual based on ISO:9001 2000 +
AS9100B
• SAE ASO9100 Rev D Quality Management System Requirements for
Aviation, Space, and Defense Organizations
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SECTION 3: TERMS AND DEFINITIONS
3.1 Quality Management System Definitions
Can – Indicates a possibility or a capability
Corrective Action – Action to eliminate the cause of a detected
nonconformity or other undesirable situation.
Customer Owned Property – Any type of instrumentation, product
or containers that belong to a customer.
Direct Line Feed – The Process or system associated with the
effecting of delivery of components direct to the point of use at a
customer’s premises.
Distributors – Organization carrying out the purchase, storage,
splitting pf quantities and sales of products without affecting
product conformance.
First Article Inspection (FAI) - Provides objective evidence
that engineering, design and specification requirements are
understood, fulfilled, verified and recorded.
May – Indicates a permission
Must – Indicates a requirement Should – Indicates a
recommendation
Preventative Action – Action to eliminate the cause of a
potential nonconformity or other undesirable potential
situation.
Product – The end item result of meeting all contract terms and
conditions. (e.g.: manufactured goods)
Quality Audits - A systematic and independent examination to
determine whether quality activities and related results comply
with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
Quality Policy – Overall intentions and direction of Pete
Pacific Machineworks related to quality as formally expressed by
Top Management.
Quality Records – Documentation of those activities wherein
records of said activities must be maintained will be specified in
the procedure or work instruction level documents, as
applicable.
Repair - Alternative manufacturing techniques, methods,
materials, or processes which may bring product into full
compliance with applicable drawings and specifications.
Rework - Additional operations that are not part of the basic
production process flow. These additional operations will achieve
full compliance to the product with applicable drawings and
specifications.
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Shall – Indicates a requirement
Sub-Tier Suppliers - Also known as sub-suppliers or subcontract
suppliers
Traceability – The ability to trace history, application or
location of an item or activity or similar items or activities, by
means of recorded identification.
3.2 Quality Management System Pete Pacific Acronyms
ASL: Approved Supplier List
CAR: Corrective Action Request
CDR: Critical Design Review
COTS: Commercial off the Shelf Supplier
ECR: Engineering Change Request
FAI: First Article of Inspection
FAIR: First Article Inspection Report
FAR: Failure Analysis Report
FIFO: First-In, First-Out
FMEA: Failure Modes and Effects Analysis
FOD: Foreign Object Debris/Damage
ITAR: International Traffic in Arms Regulation
NCR: Non-Conformance Report
PDR: Preliminary Design Review
PO: Purchase Order
QMS: Quality Management System
RCCA: Root Cause and Corrective Action
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SECTION 4: CONTEXT OF THE ORGANIZATION
4.1 Understanding the Organization and Its Context
Pete Pacific Machineworks has established, documented,
implemented and maintains a Quality Management System (QMS) at Pete
Pacific that is continually improved for effectiveness and meets
the requirements of ISO/TS 16949 and AS9100.
Pete Pacific determines external and internal issues that are
relevant to its purpose and its strategic direction and that affect
its ability to achieve the intended result(s) of its quality
management system. Pete Pacific monitors and reviews information
about these external and internal issues.
4.2 Understanding the Needs and Expectations of Interested
Parties
Due to their effect or potential effect on Pete Pacific
Machineworks' ability to consistently provide products and services
that meet customer and applicable statutory and regulatory
requirements, Pete Pacific Machineworks determines:
a) the interested parties that are relevant to the quality
management system; b) the requirements of these interested parties
that are relevant to the quality
management system.
Pete Pacific Machineworks monitors and reviews information about
these interested parties and their relevant requirements.
4.3 Determining the Scope of the Quality Management System Pete
Pacific Machineworks has determined the boundaries (processes as
defined in
Attachment A) and applicability of the quality management system
to establish its scope. When determining this scope, Pete Pacific
Machineworks considers:
a) the external and internal issues referred to in 4.1; b) the
requirements of relevant interested parties referred to in 4.2; c)
the products and services of Pete Pacific Machineworks. Pete
Pacific applies all the requirements of ISO 9001:2015 and AS9100
Rev D if they are
applicable within the determined scope of its quality management
system.
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Scope Statement: Manufacturing company specializing in the
machining of precision aerospace parts. The scope and boundaries of
this QMS includes processes for continual improvement of the system
and the assurance of conformity to customer and applicable
regulatory requirements. Not-applicable to the scope of this manual
and the QMS is “Design and Development”, as Pete Pacific
Machineworks does not design products.
4.4 Quality Management System and Its Process
While implementing and maintaining the QMS, Pete Pacific
Machineworks;
a) Identifies processes needed for the QMS and their application
throughout the organization (see Process Map);
b) Determines the sequence and interaction of these processes
(see Process Map); c) Determines the criteria and methods required
to ensure effective operation and control
of these processes; d) Ensures the availability of resources and
information necessary to support the operation
and monitoring of these processes; e) Measures, monitors, and
analyzes these processes and; f) Implements action necessary to
meet planned goals and continual improvement. This is
achieved through the Management review process, operational
departmental meetings, and the results of internal audits.
Pete Pacific manages these processes in accordance with the
requirements of the ISO/TS 16949 and AS9100 Standards. Pete Pacific
outsources products and special processes used in the manufacture
products. The QMS is extended to these suppliers as described in
7.4
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SECTION 5: LEADERSHIP
5.1 Leadership and Commitment
5.1.1 General
Top management demonstrate leadership and commitment with
respect to the quality management system by:
a) taking accountability for the effectiveness of the quality
management system; b) ensuring that the quality policy and quality
objectives are established for the quality
management system and are compatible with the context and
strategic direction of Pete Pacific Machineworks;
c) ensuring the integration of the quality management system
requirements into Pete Pacific's business processes;
d) promoting the use of the process approach and risk-based
thinking; e) ensuring that the resources needed for the quality
management system are available; f) communicating the importance of
effective quality management and of conforming to
the quality management system requirements; g) ensuring that the
quality management system achieves its intended results; h)
engaging, directing. and supporting persons to contribute to the
effectiveness of the
quality management system; promoting improvement; i) supporting
other relevant management roles to demonstrate their leadership as
it
applies to their areas of responsibility.
5.1.2 Customer Focus Top management demonstrates leadership and
commitment with respect to customer focus by ensuring that:
a) customer and applicable statutory and regulatory requirements
are determined, understood, and consistently met;
b) the risks and opportunities that can affect conformity of
products and services and the ability to enhance customer
satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is
maintained;
d) 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
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5.2 Quality Policy
Pete Pacific has made the business decision to develop and
implement an effective Quality Management Systems (QMS). The
implementation of the QMS is intended to improve and sustain the
overall performance of our business, products and services.
Examples of the benefits include:
• the ability to consistently provide products and services that
meet customer and applicable Statutory and Regulatory
requirements;
• the ability to plan our processes and their interactions by
employing our effective and comprehensive QMS in our daily
operations;
• the facilitating of opportunities to enhance customer
satisfaction;
• addressing risks and opportunities associated with its context
and objectives.
We have implemented and shall maintain and continually improve
our QMS according to the International Standards through
registration and annual review.
*The QMS Manual is considered the normative basis of reference
to the International Standard and shall be used internally to
provide an overview of ISO 9001:2015 (E) requirements and how they
apply at Pete Pacific. The manual is used externally to introduce
the elements of our QMS to our customers and other external
organizations to the extent necessary.
5.2.1 Establishing the Quality Policy
Top management has established, implemented, and maintained a
quality policy that:
a) is appropriate to the purpose and context of Pete Pacific and
supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality
management system. Refer to Section 1.3 of this Quality Manual for
Pete Pacific’s Quality Policy Statement
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5.2.2 Communicating the Quality Policy
Operations Management has been actively involved in implementing
the quality management system (QMS). It has provided the vision and
strategic direction for the growth of the QMS, and established
quality objectives and the quality policy. Currently, Monthly
Meetings are being held between the following members:
a) Vice President of Operations b) Operations Manager c) Project
Coordinator d) Purchasing e) Quality Control Manager (maintain
minutes)
To continue to provide leadership and show commitment to the
improvement of the QMS, management will do the following.
a) Communicate the importance of meeting customer, statutory,
and regulatory requirements.
b) Establish quality objectives c) Establish the quality policy.
d) Conduct quarterly management reviews. e) Ensure the availability
of resources
5.3 Organizational roles, Responsibilities, and Authorities
5.3.1 General
The Organization Chart (see Attachment B) has been established
to provide the interrelation and reporting structure of personnel
within the organization. The top management team is responsible for
overseeing and managing the overall effectiveness and compliance of
the QMS. Due to the size of the company, a single person may be
appointed multiple roles/positions. The top management team has the
following responsibilities and authorities to:
a) communicate to the organization the importance of meeting
customer as well b) as statutory and regulatory requirements; c)
establish a company Quality Policy; d) establish Quality
Objectives; e) conduct Management reviews; f) ensure the
availability of resources.
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g) ensure QMS conforms to the requirements of international
standard ISO 9001:2015(E) and SAE AS9100D;
h) ensure interaction of processes and their ability to achieve
planned results; i) report to top management on the results
achieved by the QMS, possibilities for
improvements and the needs of changes or innovations; j)
maintain QMS integrity when planning and implementing changes; k)
promote awareness of customer focus throughout the organization; l)
act as a liaison with external parties such as customers or
auditors on matters relating to
the QMS; m) resolve all matters pertaining to quality
issues.
The top management team has the organizational freedom and
unrestricted access to
resolve matters pertaining to Quality Management System as well
as to be the Company liaison with external parties, including our
customers and vendors on all matters relating to the QMS.
The Management Team of Pete Pacific Machineworks., as shown
below, has been empowered and made responsible by the President.
This team is committed to and responsible to;
President/Owner – Responsible to ensure a formal QMS is
documented, implemented, maintained and continuously improved by
the Management Team. Ensures the General Manager and Management
Team is supported in all resource decisions and is promoting the
visions and operating philosophies of the owners. Responsible to
ensure the Business Plan is implemented by the General Manager and
Management Team.
Business Manager/Treasurer – Responsible to direct and
coordinate activities of the Management Team to obtain optimum
efficiency and economy of operations and maximize profits. Works
with the company owners in formulating and administering corporate
policies. Formulates and administers company policies and develops
long-range goals and objectives. Reviews analyses of activities,
costs, operations, and forecast data to determine the company’s
progress towards stated goals and objectives. Confers with owners
and members of the management team to review achievements and
discuss required changes in goals or objectives resulting from
current status and conditions. Directs and coordinates promotion of
products manufactured, or services performed to develop new
markets, increase share of market, and obtain competitive position
in industry. Confers with administrative personnel and reviews
activity, operating, and sales reports to determine changes in
programs or operations required. Directs preparation of directives
to management team outlining policy, program, or operations changes
to be implemented. Promotes organization in industry, manufacturing
or trade associations. Responsible for the maintenance of all
facilities of Pete Pacific and regulatory compliance as well as
working with the Director of Safety to develop safety programs.
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Responsible for the Maintenance and Tooling departments.
Responsible for the Maintenance process.
Sales, Purchasing and Business Development Manager – Responsible
for bringing new business and repeat business into Pete Pacific
Machineworks, develop and maintain relationships with our
customers, and communicate customer issues as received. Responsible
for the estimating activities. Ensure initial contract review is
performed for new projects and accounts and new business with
existing accounts. Responsible for the Sales & Marketing,
Estimating, and Contract Review processes.
Director of Quality, Safety, and Maintenance – Responsible to
ensure processes needed for the QMS are established, implemented
and maintained, reporting to top management on the performance of
the QMS, and ensuring the promotion of awareness of customer
requirements. Responsible for Management Review scheduling, agenda
and minutes. Responsible for Quality Engineering, Inspection, and
the Document Control center, as well as Safety and OSHA compliance.
Responsible for the Management Review, Corrective & Preventive
Action, Document Control, Internal Audit, and Inspection &
Calibration processes. The Director of Quality and Safety is the
Management Representative. The Director of Quality has the
organizational freedom to resolve matters pertaining to
quality.
Office Administration – Responsible for the financial accounting
of the business, payroll, and information technology. Responsible
for the AR & AP and Information Technology processes.
Responsible for the cost accounting, and special reporting of
financials as required.
Human Resource Manager – Responsible for human resources.
Responsible for the identification of required education, training,
experience, job responsibilities, hiring, corrective action
(employee discipline), and promotions. Responsible for aiding other
managers to ensure that training is adequate for all personnel.
Responsible for the Training process.
Production/Control Manager– Responsible for Fabrication,
Stamping, Welding, Spot-welding, Assembly, Shipping and Receiving
of materials, and Inventory Management. Responsible for the quality
of the product shipped to our customers and the resolution of any
corrective actions generated involving manufacturing. Responsible
for the execution of any manufacturing procedures and processes,
all manufacturing work instructions, and in-process inspection
instructions. Responsible for the Inventory,
Receiving/Pack/Label/Ship, and Manufacturing & Tool Maintenance
processes. Responsible for the Purchasing and Production Control
planning processes. The quality of purchased materials and services
are the responsibility of the Purchasing Department. Purchasing
shall establish and maintain records, which document the
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sub-contractor’s ability to supply parts, and material that
conforms to specifications. It is the responsibility of the
production control personnel to conduct a contract review on repeat
production orders. Responsible for the Scheduling and Purchasing
& Supplier Development processes.
5.3.2 Responsibility for Quality
All personnel are responsible for product quality and have the
authority to stop production to correct quality problems. All
shifts are staffed with personnel in charge of ensuring product
quality. Personnel are informed about corrective action of products
or processes which do not conform to requirements in their
manufacturing areas. Supervisors and Group Leaders play an
instrumental role in this process.
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SECTION 6: PLANNING
6.1 Actions to Address Risks and Opportunities
When planning our QMS, Pete Pacific has taken into consideration
potential issues and has determined the risks and opportunities
that need to be addressed to:
a) provide assurance that the QMS can achieve its intended
result; b) enhance desirable effects; c) prevent, or reduce,
undesired effects; d) achieve improvement;
Pete Pacific has planned actions to address the above risks and
opportunities and has initiated appropriate procedures to integrate
and implement appropriate actions into our QMS including the
evaluation of the effectiveness our QMS processes. Any actions
taken to address risks and opportunities shall be proportionate to
the potential impact on the conformity of products and
services.
6.2 Quality Objectives
Quality Objectives are defined and measured by members of the
Top Management Team and are reviewed and documented during the
Management Review meetings. Once yearly, at the Management Review
Meeting, Quality Objectives will be reviewed, and if required,
changes made. Responsibility for Quality Objectives is identified
on the Management Review minutes. Quality objectives are created to
ensure product requirements are met and are established at relevant
functions and levels within the organization. These objectives are
measurable and consistent with the Quality Policy. Quality
objectives are strategic, apply to the entire Company and
shall:
a) be consistent with the Quality Policy; b) be measurable and
monitored; c) take into account applicable requirements; d) be
communicated; e) be updated as appropriate; f) be relevant to
conformity of products, services and enhance customer
satisfaction.
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6.3 Planning of Changes
When changes to the QMS are deemed necessary, Pete Pacific shall
ensure the change will comply with the requirements of ISO
9001:2015 (E), SAE AS9100D and shall consider:
a) the purpose of the changes and their potential consequences;
b) the integrity of QMS; c) the availability of resources; d) the
allocation or reallocation of responsibilities and authorities.
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SECTION 7: SUPPORT
7.1 Resources
7.1.1 General Pete Pacific determines and provides the resources
needed for the establishment,
implementation, maintenance, and continual improvement of the
quality management system. Pete Pacific considers:
a) management review meeting inputs and outputs; b) capabilities
and constraints on existing internal and external resources; c)
requirements and expectations provided by our external
providers/vendors.
7.1.2 People Pete Pacific identifies personnel training needs,
provides required training, and
evaluates the effectiveness of the training provided. Personnel
assigned to perform specific tasks, operations and processes are
qualified on the basis of appropriate education, experience or
training. Employees are made aware of the relevance and importance
of their activities and how they contribute to the achievement of
quality objectives. Records of personnel qualifications and
training are maintained.
7.1.3 Infrastructure
Pete Pacific has determined and provided resources necessary for
the establishment, implementation, maintenance and continual
improvement of the QMS. Our infrastructure resource considerations
include:
a) buildings, workspace and associated utilities; b) equipment
including (hardware and software); c) transportation resources; d)
information and communication technology.
As new infrastructure requirements are determined to be
necessary, they will be documented in quality plans and other
documents as required.
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7.1.4 Environment for the Operation of Processes
Management identifies and manages the human and physical factors
of the work environment considered to be important to control
processes and to achieve conforming of products and services.
Evaluations include:
a) assessment of product requirements to identify where human
and/or physical factors will affect product quality this is also
conducted during advanced product quality planning,
b) Assessment of current working environment conditions to
determine if the work environment is suitable to achieve conforming
product.
c) Implementation of work environment improvements needed to
achieve conforming product.
d) Continual assessment of work environment to ensure that
adequate human and physical factors are maintained.
7.1.5 Monitoring and Measuring Resources
Pete Pacific determines and provides the resources needed to
ensure valid and reliable results when monitoring or measuring is
used to verify the conformity of products and services to
requirements. Pete Pacific ensures that the resources provided:
a) is suitable for the specific type of monitoring and
measurement activities being undertaken;
b) is maintained to ensure their continuing fitness for their
purpose.
Pete Pacific retains appropriate documented information as
evidence of fitness for purpose of the monitoring and measurement
resources.
Measurement Traceability
When measurement traceability is a requirement, or is considered
by Pete Pacific to be an essential part of providing confidence in
the validity of measurement results, measuring equipment is:
a) calibrated or verified, or both, at specified intervals, or
prior to use, against measurement standards traceable to
international or national measurement standards; when no such
standards exist, the basis used for calibration or verification is
retained as documented information;
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b) identified in order to determine their status;
c) safeguarded from adjustments, damage, or deterioration that
would invalidate the
calibration status and subsequent measurement results.
Pete Pacific establishes, implements, and maintains a process
for the recall of monitoring and measuring equipment requiring
calibration or verification Pete Pacific maintains a register of
the monitoring and measuring equipment. The register includes the
equipment type, unique identification, location, and the
calibration or verification method, frequency, and acceptance
criteria. Calibration or verification of monitoring and measuring
equipment is carried out under suitable environmental conditions
(see 7.1.4). Pete Pacific determines if the validity of previous
measurement results has been adversely affected when measuring
equipment is found to be unfit for its intended purpose and takes
appropriate action as necessary.
7.1.6 Organizational Knowledge Pete Pacific determines the
knowledge necessary for the operation of its processes and
to achieve conformity of products and services. This knowledge
is maintained and be made available to the extent necessary. When
addressing changing needs and trends, Pete Pacific considers its
current knowledge and determine how to acquire or access any
necessary additional knowledge and required updates.
7.2 Competence
7.2.1 General
Pete Pacific Machineworks;
a) Determines the necessary competence for personnel performing
work affecting product quality;
b) Provides training and takes other actions to satisfy these
needs; c) Evaluates the effectiveness of the actions taken; d)
Ensures that its personnel are aware of the relevance and
importance of their activities
and how they contribute to the achievement of the quality
objectives, and; e) Maintains appropriate records of education,
training, skills and experience.
Actions taken to satisfy the above include, but are not limited
to;
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a) Completion of “Pete Pacific Staffing Requisition” forms,
identifying required skills and knowledge for the positions being
filled;
b) Using detailed job descriptions for key positions; c)
Providing on the job, class oriented on-site, seminar off-site, and
collegiate training,
and; d) Documenting and reviewing training effectiveness
feedback from employees and
supervisors;
7.2.2 Training on the job
On-the job training is performed as required and deemed
appropriate by departmental supervisors and managers. Communication
to employees whose work can affect quality and the consequences to
the customer if nonconformities are found is done by;
a) New employee orientation; b) Communication between employees
and supervisors; c) Communication to employees about Quality
objectives and how they affect these
measures; d) Internal Audit communication to employees.
7.2.3 Employee motivation and empowerment
Employee motivation towards achieving quality objectives,
continual improvement, and promote innovation is done in different
forms as follows;
a) New employee orientation, b) Involvement of all levels of
personnel in quality planning, decision making (QPR
process), c) A comprehensive performance evaluation process
which details specific performance
criteria, as well as evaluating and developing goals for each
employee, including quality and continual improvement,
d) Performance evaluations done at shortened intervals when
justified by employee performance,
e) Periodic rewards for successful program launch, f) Annual
company rewards, g) Company supported events, h) Employee
surveys.
Measurement of the extent of which the personnel are aware of
the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives is done as
part of the Internal Audit process.
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7.3 Awareness Pete Pacific ensures that persons doing work under
Pete Pacific 's control are aware of:
a) the quality policy; b) relevant quality objectives; c) their
contribution to the effectiveness of the quality management system,
including the
benefits of improved performance; d) the implications of not
conforming with the quality management system requirements; e)
relevant quality management system documented information and
changes thereto; f) their contribution to product or service
conformity; g) their contribution to product safety; h) the
importance of ethical behavior,
7.4 Communication Pete Pacific determines the internal and
external communications relevant to the
quality management system, including:
a) on what it will communicate; b) when to communicate; c) with
whom to communicate; d) how to communicate; e) who
communicates.
Documentation Requirements
Pete Pacific Machineworks documented QMS includes;
a) A documented quality policy and quality objectives; b) A
Quality manual; c) Documented procedures, including those required
by the ISO 9001 and AS9100
Standards; d) Documentation Pete Pacific Machineworks, LLC
requires to ensure the effective
planning, operation and control of our processes; e) Records
required by the ISO 9100:2015 and SAE AS9100D Standards. f)
Applicable Regulatory Authority requirements.
The extent of our documentation has been determined by;
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a) The needs of a small, fast-paced organization concerned with
the manufacturing of products to our customer’s requirements;
b) The complexity of our operations; c) The competence of the
employees of Pete Pacific Machineworks, LLC.
Documentation is categorized as follows;
Level 1 – Business Plan and Quality Management System Manual
Level 2 – Supporting Quality System Procedures
Level 3 – Work Instructions, Customer Prints, Standards, etc
7.5 Documented Information
7.5.1 General Pete Pacific Machineworks documented QMS
includes;
a) A documented quality policy and quality objectives; b) A
Quality manual; c) Documented procedures, including those required
by the ISO 9001 and AS9100
Standards; d) Documentation Pete Pacific requires to ensure the
effective planning, operation and
control of our processes; e) Records required by the ISO/TS
16949 and AS9100 Standards. f) Applicable Regulatory Authority
requirements.
The extent of our documentation has been determined by;
a) The needs of a small, fast-paced organization concerned with
the manufacturing of products to our customer’s requirements;
b) The complexity of our operations; c) The competence of the
employees of Pete Pacific Machineworks.
Documentation is categorized as follows;
Level 1 – Business Plan and Quality Management System Manual
Level 2 – Supporting Quality System Procedures
Level 3 – Work Instructions, Customer Prints, Standards,
etc.
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7.5.2 Creating and Updating When creating, and updating
documented information, Pete Pacific ensures appropriate:
a) identification and description (e.g., a title, date. author,
or reference number); b) format (e.g., language, software version.
graphics) and media (e.g., paper, electronic); c) review and
approval for suitability and adequacy.
7.5.3 Control of Documented Information Documented information
required to support the effectiveness of our QMS is controlled to
ensure:
a) it is available and suitable for use, where and when it is
needed; b) it is adequately protected from loss of confidentiality,
improper use, or loss of
integrity. c) distribution, access, retrieval and use; d)
storage and preservation, including preservation of legibility; e)
control of changes; f) retention and disposition.
Documented information of external origin determined to be
necessary for the planning
and implementation of the QMS is identified as appropriate and
controlled in accordance with Quality System Procedures and
Forms.Document changes are coordinated with customer and/or
regulatory authorities in accordance to contract or regulatory
requirements.
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SECTION 8: OPERATION
8.1 Operational Planning and Control
Pete Pacific defines the expectation and implements controls for
each of our QMS processes. The planning of controls is required to
ensure consistent acceptability of products and services. Planning
processes include the definition of quality objectives, development
for required processes, establishment for appropriate verification
programs and the requirement for records necessary to demonstrate
the process and products conform to intended requirements.
Operational planning and control is required prior to new and/or
revised products or processes being implemented. During the
planning phase, management will identify: requirements for the
products and services; criteria for the processes and the
acceptance of products and services; resources needed to achieve
conformity to the product and service requirements; control of the
processes in accordance with the criteria; documented information
to the extent necessary to have confidence that the processes have
been carried out as planned and to demonstrate the conformity of
products and services to their requirements.
The output of operational planning and control includes
documented quality plans, resource requirements, processes,
equipment requirements, procedures, test data, and design
outputs.
Operational Planning and Control Map See Attachment C
8.1.1 Operational Risk Management
Pete Pacific plans, implements, and controls a process for
managing operational risks to the achievement of applicable
requirements, which includes as appropriate to Pete Pacific and the
products and services:
a. assignment of responsibilities for operational risk
management; b. definition of risk assessment criteria (e.g.,
likelihood, consequences, risk
acceptance); c. identification, assessment, and communication of
risks throughout operations; d. identification, implementation, and
management of actions to mitigate risks that
exceed the defined risk acceptance criteria; e. acceptance of
risks remaining after implementation of mitigating actions.
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8.1.2 Configuration Management
Pete Pacific plans, implements, and controls a process for
configuration management as appropriate to Pete Pacific and its
products and services in order to ensure the identification and
control of physical and functional attributes throughout the
product lifecycle. This process includes:
a. control of product identity and traceability to requirements,
including the implementation of identified changes;
b. assurance that the documented information (e.g.,
requirements, design, verification, validation and acceptance
documentation) is consistent with the actual attributes of the
products and services.
8.1.3 Product Safety
Pete Pacific plans, implements, and controls the processes
needed to assure product safety during the entire product life
cycle, as appropriate to Pete Pacific and the product.
8.1.4 Prevention of Counterfeit Parts
Pete Pacific plans, implements, and controls processes,
appropriate to Pete Pacific and the product, for the prevention of
counterfeit or suspect counterfeit part use and their inclusion in
product(s) delivered to the customer.
8.2 Requirements for Products and Services/Customer-related
Processes and Outsourcing
8.2.1 Customer Communication Communication with customers
includes:
a. providing information relating to products and services; b.
handling enquiries, contracts, or orders, including changes; c.
obtaining customer feedback relating to products and services,
including
customer complaints; d. handling or controlling customer
property; e. establishing specific requirements for contingency
actions, when relevant.
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8.2.2 Determination of Requirements Related to the Products and
Services
Pete Pacific requires that all customer specific requirements
for products and services are clearly defined by the customer
including but not limited to:
a) applicable statutory and regulatory requirements; b)
requirements considered necessary by Pete Pacific; c) acceptance
that Pete Pacific can meet the products and services provided.
8.2.3 Review of Requirements Related to the Product
Pete Pacific ensures we have the ability to meet the
requirements for products and services to be offered to customers.
Management conducts a contract/product review prior to committing
to supply products and services to a customer. The review process
at a minimum includes:
a) requirements specified by the customer, including the
requirements for delivery and postdelivery activities;
b) requirements not stated by the customer, but necessary for
the intended use, when known;
c) requirements specified by the organization; d) statutory and
regulatory requirements applicable to the products and services; e)
contract or order requirements differing from those previously
expressed.
Pete Pacific ensures contracts, purchase orders or other
requirements differing from those previously defined, are reviewed
and approved prior to incorporating into our business systems. We
retain applicable documented information of the initial review and
on any new/revised customer or applicable external party
requirements for the products and services provided.
8.2.4 Changes to Requirements for Products and Services
Pete Pacific ensures that relevant documented information is
amended, and that relevant persons are made aware of the changed
requirements, when the requirements for products and services are
changed.
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8.3 Design and Development for Products and Services(Not
Applicable/Excluded)
8.4 Control of Externally Provided Processes, Products,
Services, and Purchasing
8.4.1 General
Pete Pacific maintains responsibility for the quality of all
products purchased from external providers, including customer
designated sources. Procedures ensure products and services being
provided by external sources will conform to our customers’
requirements. Examples of our controls include: a documented
Approved Vendor List (AVL); the review of external provider’s
performance
Type and Extent of Control of External Provision Pete Pacific
ensures that externally provided processes, products and services
do not adversely affect our ability to consistently deliver
conforming products and services to our customers. Vendors
demonstrating inadequate performance will be required to implement
corrective actions. Poor performing vendors will be replaced.
Information for External Providers Pete Pacific uses purchase
orders to define the product or services to be purchased. Purchase
Orders are created in the company E2System, by designated
individuals within the Company. Purchasing documents are reviewed
for adequacy and approved by purchasing personnel prior to release.
Purchasing documents clearly describe the product or service to be
provided.
8.4.2 Type and Extent of Control Pete Pacific ensures that
externally provided processes, products, and services do not
adversely affect Pete Pacific 's ability to consistently deliver
conforming products and services to its customers. Pete
Pacific:
a. ensures that externally provided processes remain within the
control of its quality management system;
b. defines both the controls that it intends to apply to an
external provider and those it intends to apply to the resulting
output;
c. takes into consideration:
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1. the potential impact of the externally provided processes,
products, and services on Pete Pacific 's ability to consistently
meet customer and applicable statutory and regulatory
requirements;
2. the effectiveness of the controls applied by the external
provider; 3. the results of the periodic review of external
provider performance; 4. determines the verification, or other
activities, necessary to ensure that the
externally provided processes, products, and services meet
requirements.
Verification activities of externally provided processes,
products, and services are performed according to the risks
identified by Pete Pacific. These include inspection or periodic
testing, as applicable, when there is high risk of nonconformities
including counterfeit parts.
When externally provided, product is released for production use
pending completion of all required verification activities, it is
identified and recorded to allow recall and replacement if it is
subsequently found that the product does not meet requirements.
When Pete Pacific delegates verification activities to the
external provider, the scope and requirements for delegation are
defined and a register of delegations are maintained. Pete Pacific
periodically monitors the external provider's delegated
verification activities.
When external provider test reports are utilized to verify
externally provided products, Pete Pacific implements a process to
evaluate the data in the test reports to confirm that the product
meets requirements. When a customer or organization has identified
raw material as a significant operational risk (e.g., critical
items), Pete Pacific implements a process to validate the accuracy
of test reports.
8.4.3 Information for External Providers
Pete Pacific ensures the adequacy of requirements prior to their
communication to the external provider. Pete Pacific communicates
to external providers its requirements for:
a) the processes, products, and services to be provided
including the identification of relevant technical data (e.g.,
specifications, drawings, process requirements, work
instructions);
b) the approval of: 1. products and services; 2. methods,
processes, and equipment; 3. the release of products and
services;
c) competence, including any required qualification of persons;
d) the external providers' interactions with Pete Pacific; e)
control and monitoring of the external providers' performance to be
applied by Pete
Pacific; f) verification or validation activities that Pete
Pacific, or its customer, intends to perform
at the external provider’s premises; g) design and development
control;
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h) special requirements, critical items, or key characteristics;
i) test, inspection, and verification (including production process
verification); j) the use of statistical techniques for product
acceptance and related instructions for
acceptance by Pete Pacific; k) the need to:
1. implement a quality management system; 2. use
customer-designated or approved external providers, including
sources (e.g.,
special processes); 3. notify Pete Pacific of nonconforming
processes, products, or services and obtain
approval for their disposition; prevent the use of counterfeit
parts (see 8.1.4); 4. notify Pete Pacific of changes to processes,
products, or services, including
changes of their external providers or location of manufacture,
and obtain Pete Pacific ’s approval; flow down to external
providers applicable requirements including customer requirements;
provide test specimens for design approval,
inspection/verification, investigation, or auditing; retain
documented information, including retention periods and disposition
requirements;
l) the right of access by Pete Pacific, their customer, and
regulatory authorities to the applicable areas of facilities and to
applicable documented information, at any level of the supply
chain;
m) ensuring that persons are aware of: 1. their contribution to
product or service conformity; 2. their contribution to product
safety; 3. the importance of ethical behavior.
8.5 Production and Service Provision
8.5.1 Control of Production and Service Provision
Pete Pacific plans and implements production and service
provision under controlled conditions and as required by job
specific requirements. Examples of the controls include:
a) availability of information that define characteristics and
results to be achieved; b) availability of competent and
effectively trained personnel and adequate equipment; c)
availability and use of suitable monitoring and measuring devices
and resources; d) evidence that all manufacturing and inspection
operations have been completed as
planned; e) Manufacturing procedures, job travelers, inspection
plans, and other documents
deemed necessary, define the acceptance for manufacturing and
service operations.
The plans provide detailed instruction and guidance for all
production and service phases including the methods and equipment
to be used and workmanship criteria. Records for each job number of
products produced provide unique traceability and identify the
quantity
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manufactured and released for delivery. This record is
maintained as required by customer contract requirements.
8.5.2 Identification and Traceability
Pete Pacific identifies parts and products by suitable means
throughout production. Marking methods will be described in the
applicable operations procedures for affected departments. Where
traceability is a requirement, the Company controls and records the
unique identification of the outputs. According to the level of
traceability required by contract, regulatory or other established
requirement, our procedures provides for:
a) identification to be maintained throughout the processes
including delivery and post-delivery;
b) identification of sub-components and those of the next higher
assembly;
8.5.3 Property Belonging to Customers and External Providers
Pete Pacific exercises care with property belonging to customers
or external providers while it is under our control or being used.
Procedures are established for the control, storage, maintenance
and accounting of Customer/Government furnished materials, tooling
and equipment including data used for design, production and/or
inspection provided to the Company for the performance of work
under a specific contract or contracts.
8.5.4 Preservation
Pete Pacific preserves the conformity of parts and products
during internal processing and delivery to the intended destination
including outside services. Procedures include instructions for
identification, handling, packaging, storage and protection.
Preservation of outputs also includes, where applicable:
a) cleaning; b) prevention, detection and removal of foreign
objects; c) special handling for sensitive outputs; d) marking and
labeling including safety warnings;
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e) special handling for hazardous materials. The shipping
department ensures that documents required by the contract/order to
accompany the product are present at delivery and are protected
against loss and deterioration.
8.5.5 Post-Delivery Activities
Pete Pacific meets requirements for post-delivery activities
associated with the products and services. In determining the
extent of post-delivery activities that are required, Pete Pacific
considers:
a. statutory and regulatory requirements; b. the potential
undesired consequences associated with its products and services;
c. the nature, use, and intended lifetime of its products and
services; d. customer requirements; e. customer feedback; f.
collection and analysis of in-service data (e.g., performance,
reliability, lessons
learned); g. control, updating, and provision of technical
documentation relating to product
use, maintenance, repair, and overhaul;
h. controls required for work undertaken external to Pete
Pacific (e.g., off-site work);
i. product/customer support (e.g., queries, training,
warranties, maintenance, replacement parts, resources,
obsolescence).
When problems are detected after delivery, Pete Pacific takes
appropriate action including investigation and reporting.
8.5.6 Control of Changes
Pete Pacific reviews and control changes for production or
service provision, to the extent necessary to ensure continuing
conformity with requirements. Persons authorized to approve
production or service provision changes are identified. Pete
Pacific retains documented information describing the results of
the review of changes, the person(s) authorizing the change, and
any necessary actions arising from the review.
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8.6 Release of Product and Services
Pete Pacific monitors and measures the characteristics of the
product in receiving inspection, in process inspection, and final
inspection to verify that requirements have been met. Documented
procedures have been established for product inspection. Documented
Records and information of inspection include evidence of
conformity with the acceptance criteria and traceability to the
person authorizing the release. Records of inspection are
maintained.
8.7 Control of Nonconforming Outputs
Pete Pacific ensures that products or services that do not
conform to established requirements are identified and controlled
to prevent their unintended use or delivery. Records of
nonconformities are maintained as required and include:
a) description of nonconformity; b) description of actions
taken; c) description of concessions obtained; d) identification of
the authority deciding the action in respect of the
nonconformity
When nonconforming product is corrected, it is re-inspected to
the original specifications and requirements to ensure it conform
to customer stated requirements. When a nonconforming product is
detected after delivery, Pete Pacific will take action appropriate
to the effects or potential effects of the nonconformity.
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SECTION 9: PERFORMANCE EVALUATION
9.1 Monitoring and Measurement
9.1.1 General Pete Pacific determines:
a. what needs to be monitored and measured; b. the methods for
monitoring, measurement, analysis, and evaluation needed to
ensure valid results; c. when the monitoring and measuring is
performed; d. when the results from monitoring and measurement are
analyzed and
evaluated. Pete Pacific evaluates the performance and the
effectiveness of the quality
management system. Pete Pacific retains appropriate documented
information as evidence of the results.
9.1.2 Customer Satisfaction
Pete Pacific monitors information relating to customer
perception of our continual ability to fulfill their requirements.
Maintaining customer satisfaction is one of the principal
objectives of the QMS. Collecting and analyzing customer feedback
and complaints, and customer satisfaction is conducted during
management review. Customer satisfaction data is used by management
to identify opportunities for improvement.
9.1.3 Analysis and Evaluation
Pete Pacific Machineworks performs necessary analyses and
evaluates appropriate data and information initiated from
monitoring and measurement and uses the results to evaluate
conformity of products and services, customer satisfaction, the
performance and effectiveness of the QMS, the performance of
external providers, and the need for improvement of the QMS
.
9.2 Internal Audit
9.2.1 General
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Pete Pacific has established and documented procedures to ensure
systematic audits of the QMS are performed to ensure compliance
with the documented procedures and methods and to determine the
overall effectiveness of the system. Internal QMS audits are the
responsibility of the Internal Audit Manager (Quality Specialist)
and are conducted by qualified personnel who are independent of the
functions being audited. The audit program is designed to audit by
“process”.
9.2.2 Quality management system audit
Internal auditing will include the requirements of AS9100 Rev D,
ISO 9001:2015 and our QMS system.
9.2.3 Manufacturing process audit
Manufacturing processes are audited in different manners as
follows;
a) By QA as part of First Piece submissions; b) By Internal
Auditors as part of the process approach to auditing; c) By CSE’s
and QE’s as part of ongoing process issues arise.
9.2.4 Product audit
Product Audits will be scheduled by the Director of Quality and
Safety and completed by Internal Auditors utilizing an “Pete
Pacific Product Audit Report” sheet as a guide. The schedule will
be maintained by the Internal Audit Manager and will be based upon
customer complaints as well as internal DMR data. All product will
be audited within a three-year period from time of customer
PPAP.
9.2.5 Internal audit plans
Internal audits cover all QMS related processes, activities and
shifts, and are scheduled according to an annual plan.
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9.2.6 Internal auditor qualification
All internal auditors will be trained on the requirements of the
ISO/TS 16949:2002 standard and developed as outlined in ISO
19011.
9.3 Management Review 2
9.3.1 General
Management Review meetings will be held at least Quarterly to
ensure the continuing suitability, adequacy, and effectiveness of
our QMS. The Director of Quality and Safety will schedule the
meetings. Minutes and action items will be documented and
maintained as Records. At this time, we will review the QMS,
Quality Objectives, Quality Policy, and identify any required
changes and areas for improvement. Attendees of this meeting
are:
• President and Owner
• Business Manager
• Sales and Purchasing Manager
• Director of Quality, Safety, and Maintenance
• Human Resource Manger
• Office Administrator
• Quality Specialist (Internal Audit Manager)
• Production Control Supervisor
• Production Supervisor
• Business Development Manager
9.3.2 Management Review Inputs The management review is planned
and carried out takes into consideration:
a) the status of actions from previous management reviews; b)
changes in external and internal issues that are relevant to the
quality management
system; c) information on the performance and effectiveness of
the quality management system,
including trends in: 1. Customer satisfaction and feedback from
relevant interested parties;
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2. The extent to which quality objectives have been met;
3. Process performance and conformity of products and
services;
4. Nonconformities and corrective actions;
5. Monitoring and measurement results;
6. Audit results;
7. The performance of external providers;
8. On-time delivery performance; d) the adequacy of resources;
e) the effectiveness of actions taken to address risks and
opportunities (see 6.1); f) opportunities for improvement.
9.3.3 Management Review Outputs The outputs of the management
review include decisions and actions related to:
a) opportunities for improvement; b) any need for changes to the
quality management system; c) resource needs; d) risks
identified.
Pete Pacific retains documented information as evidence of the
results of management reviews.
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SECTION 10: IMPROVEMENT
10.1 General
Pete Pacific continually improves the effectiveness of the QMS
through the use of the Quality Policy, Quality Objectives, Audit
Results, Analysis of Data, Corrective and preventive Actions and
management Review. Pete Pacific shall determine and select
opportunities for improvement and implement any necessary actions
to meet Customer requirements and enhance satisfaction by:
a) Improving Products and Services to meet requirements as well
as to address future needs and expectations.
b) Correcting, preventing or reducing undesired effects c)
Improving the performance and effectiveness of the QMS
NOTE: Improvement could include; Correction, Corrective Action,
Continual Improvement, Breakthrough Change, Innovation and
Re-organization.
10.2 Nonconformity and corrective action
Pete Pacific Machineworks initiates actions to eliminate the
cause of nonconformities in order to prevent recurrence. Corrective
actions are appropriate to the effects of the nonconformities
encountered. When nonconformity occurs, corrective action
procedures are initiated and implemented. Examples of actions taken
include:
a) taking action to control and correct it; b) reviewing and
analyzing the nonconformity; c) determining the causes of the
nonconformity; d) determining if similar nonconformities exist, or
could potentially occur; e) implementation of any action needed; f)
review of the effectiveness of any corrective action taken; g)
updating risks and opportunities determined during planning, if
necessary; h) making changes to the QMS, if necessary.
See Attachment D for Nonconformity Corrective Action Process
Map
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10.3 Continual Improvement
Pete Pacific shall continually improve the suitability, adequacy
and effectiveness of the QMS. Pete Pacific shall consider the
results of analysis and evaluation, and the outputs from Management
Reviews, to determine if there are needs or opportunities that
shall be addressed as part of Continual Improvement. Pete Pacific
shall monitor the implementation of Improvement Activities and
evaluate the effectiveness of the results. NOTE: Continual
Improvement opportunities can include; lessons learned, problem
resolutions and the benchmarking of best practices.
Pete Pacific is a contract manufacturer by nature, servicing
many different customers in both low volume and high-volume
production. In cases where production volumes / and or automotive
customers volumes justify a focus on reduction of variation and in
product characteristics and manufacturing process parameters,
process improvement focus will be applied by;
• Comparing current statistical analysis against historic
data,
• Performing manufacturing reviews focusing on elements of lean
manufacturing for improvement.
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QUALITY SYSTEMS MANUAL REVISION INDEX Revision Description
Revision
Date Revised By
Initial Release Revision A
2/26/2019 Darrin Chan
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ATTACHMENT A
Context of the Organization
Leadership Planning Support
Business Process
Input
Customer Requirements Sales Purchasing Manufacturing
Realization Process Output
Product Finalization
Performance Evaluation
Quallity Conformance
Improvement
Support Process
Process Map
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ATTACHMENT B
Owner - President
Business Manager -Treasurer
Production Control
Sales
Purchasing
Quality
Safety
Maintenance
Production Manager
Estimating
CNC MillingCNC TurningGrinding/HonngMaterial
ManagementShipping/Recieving
Business Developer
Project Management
Office Administration
Human Resources
Organization Chart
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ATTACHMENT C
c
Operational Planning and Control
Opertional Planning
and Control
Management Review
Product Details
Customer Requirements
Contract Review
Product Quality Plan (If
Applicable)
Manufacturing Process Sheet
Quality Planning
Flowing Down
Customer Requiremnts
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ATTACHMENT D