Complete Quality Systems Manual...Complete Quality Systems Manual Based on ISO 9001:2015 + AS9100D Certification Pending Initial Release Revision A PETE PACIFIC MACHINEWORKS, LLC 1622

Rev. A 1 of 49 PRINTED COPIES OF THIS DOCUMENT ARE UNCONTROLLED

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]


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: ..........................................................................................................................


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


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 .................................................................................................................................. 47

Attachment B .................................................................................................................................. 47

Operational Planning and Control .......................................................................................................... 48

Attachment C................................................................................................................................... 48

Attachment D .................................................................................................................................. 49

Nonconformity Corrective Action Process .......................................................................................... 49

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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


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.


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


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.”


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


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.


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


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.


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


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


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


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.


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.


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


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.


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.


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.


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.


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;


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;


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.


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;


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.


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.


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.


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.


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.


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:


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;


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


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;


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.


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.


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


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.


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;


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.


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


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.


QUALITY SYSTEMS MANUAL REVISION INDEX Revision Description Revision

Date Revised By

Initial Release Revision A

2/26/2019 Darrin Chan


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


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


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


ATTACHMENT D