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Robust Rotorcraft Industries Quality Manual Photocredit: Lundstrom & Associates Architects December 9 th , 2014 ISE 527 Team 5: Katherine Rose Beach Xiaoting Ren Shahryar Soha Zain Bokhari Christopher Gordon Fu-Li Lin

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Page 1: ISE 527 Team 5 ISO Quality Manual

Robust Rotorcraft Industries

Quality Manual

Photocredit: Lundstrom & Associates Architects

December 9th, 2014

ISE 527 Team 5:

Katherine Rose Beach

Xiaoting Ren

Shahryar Soha

Zain Bokhari

Christopher Gordon

Fu-Li Lin

Page 2: ISE 527 Team 5 ISO Quality Manual

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Robust Rotorcraft Industries

Gardena, California

Title

Quality Manual

Document Number

RRI101

Revision

A

Document Approval

Approval Signature Date

Katherine Beach ELECTRONIC SIGNATURE ON FILE 2014/12/02

Zain Bokhari ELECTRONIC SIGNATURE ON FILE 2014/12/02

Christopher Gordon ELECTRONIC SIGNATURE ON FILE 2014/12/02

Fu-Li Lin ELECTRONIC SIGNATURE ON FILE 2014/12/02

Xiaoting Ren ELECTRONIC SIGNATURE ON FILE 2014/12/02

Shahryar Soha ELECTRONIC SIGNATURE ON FILE 2014/12/02

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Table of Contents 1 Scope ............................................................................................................................................ 5 

1.1  General ............................................................................................................................. 5 

1.1.1 Mission ............................................................................................................................ 6 

1.1.2 Vision .............................................................................................................................. 6 

1.1.3 Values ............................................................................................................................. 6 

1.2 Applications ........................................................................................................................... 6 

2 Normative References ................................................................................................................. 7 

3 Terms and Definitions .................................................................................................................. 7 

4. Quality Management System ..................................................................................................... 8 

4.1 General Requirements .......................................................................................................... 8 

4.2 Documentation requirements............................................................................................. 10 

4.2.1 General ......................................................................................................................... 10 

4.2.2 Quality manual ............................................................................................................. 10 

4.2.3 Control of documents ................................................................................................... 10 

4.2.4 Control of records ......................................................................................................... 10 

5 Management Responsibility ...................................................................................................... 11 

5.1 Management Commitment ................................................................................................. 11 

5.2 Customer Focus ................................................................................................................... 11 

5.3 Quality Policy ....................................................................................................................... 11 

5.4 Planning ............................................................................................................................... 12 

5.4.1 Quality Objectives ......................................................................................................... 12 

5.4.2 Quality management system planning ......................................................................... 13 

5.5 Responsibility, authority, and communication ................................................................... 13 

5.5.1 Responsibility and authority ......................................................................................... 13 

5.5.2 Management Representative ....................................................................................... 14 

5.5.3 Internal Communication ............................................................................................... 15 

5.6 Management review ........................................................................................................... 15 

5.6.1 General ......................................................................................................................... 15 

5.6.2 Review Input ................................................................................................................. 15 

5.6.3 Review Output .............................................................................................................. 16 

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6 Resource management .............................................................................................................. 16 

6.1 Provision of resources ......................................................................................................... 16 

6.2 Human resources ................................................................................................................ 16 

6.2.1 General ......................................................................................................................... 16 

6.2.2 Competence, Training and Awareness ......................................................................... 17 

6.3 Infrastructure ...................................................................................................................... 18 

6.4 Work environment .............................................................................................................. 18 

7        Product Realization ........................................................................................................ 19 

7.1     Planning of Product Realization ................................................................................. 19 

7.2     Customer‐Related Processes ...................................................................................... 20 

7.2.1  Determination of Requirements Related to the Product ....................................... 20 

7.2.2  Review of Requirements Related to the Product ................................................... 21 

7.2.3  Customer Communication ...................................................................................... 21 

7.3     Design and Development ........................................................................................... 22 

7.3.1  Design and Development Planning ......................................................................... 22 

7.3.2  Design and Development Inputs ............................................................................. 22 

7.3.3  Design and Development Outputs .......................................................................... 23 

7.3.4  Design and Development Review ........................................................................... 23 

7.3.5  Design and Development Verification .................................................................... 24 

7.3.6  Design and Development Validation ...................................................................... 24 

7.3.7  Control of Design and Development Changes ........................................................ 24 

7.4     Purchasing .................................................................................................................. 25 

7.4.1  Purchasing Process ................................................................................................. 25 

7.4.2  Purchasing Information .......................................................................................... 25 

7.4.3  Verification of Purchased Product .......................................................................... 26 

7.5 Production and Service Provision ....................................................................................... 26 

7.5.1 Control of Production and Service Provision ................................................................ 26 

7.5.2 Validation of Processes for Production and Service Provision ..................................... 27 

7.5.3 Identification and Traceability ...................................................................................... 27 

7.5.4 Customer Property ....................................................................................................... 27 

7.5.5 Preservation of Product ................................................................................................ 28 

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7.6 Control of Monitoring and Measuring Equipment ............................................................. 28 

8 Measurement, Analysis and Improvement ............................................................................... 29 

8.1 General ................................................................................................................................ 29 

8.2 Monitoring and Measurement ............................................................................................ 29 

8.2.1 Customer Satisfaction ................................................................................................... 29 

8.2.2 Internal Audit ................................................................................................................ 29 

8.2.3 Monitoring and Measurement of Processes ................................................................ 30 

8.2.4 Monitoring and Measurement of Product ................................................................... 30 

8.3 Control of Nonconforming Product .................................................................................... 30 

8.4 Analysis of Data ................................................................................................................... 31 

8.5 Improvement ..................................................................................................................... 31 

8.5.1 Continual Improvement ............................................................................................... 31 

8.5.2 Corrective Action .......................................................................................................... 31 

8.5.3 Preventive Action ......................................................................................................... 32 

APPENDIX A: ASSOCIATED FORMS ................................................................................................ 33 

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1 Scope

Our engineering firm, Robust Rotorcraft Industries (RRI), was incepted as a startup design organization and primarily funded by USC alumni, family, and friends interested in artisanal projects that demonstrate Trojan pride and commitment to quality. We decided to focus our attention on paper helicopters and their complementary release systems, because they are unique displays of innovation and creativity.

Our founding team consists of six talented USC Viterbi engineers with experience in detail-oriented, hands-on projects. We have devoted ourselves to researching and developing high quality stylish paper helicopters with a competitive advantage in current markets. Since the paper helicopter market keeps thriving, we at Robust Rotorcraft Industries are striving to introduce our products to the customers and expand our business in the near future.

We hope to create a product that can find a special place in your home. A Flight-On! helicopter should be within an arm’s reach, ready for deployment then launch. The graceful flight that follows should be the highlight of your next Thanksgiving family get-together.

1.1 General

Moving forward, our goal is to provide the highest quality paper helicopters and release systems available for our current market of USC clients, USC-affiliated parties and their associated networks. We will utilize social media platforms to expand our brand to national and international customers. In extension, our financial team will weigh the pros and cons of investments in foreign markets and potentially deploying production units overseas. Our company’s plan is to start selling 20 paper helicopters in the first month of operations, and grow linearly every subsequent month. Along this trajectory, we will hopefully reach our target of 1,000 helicopters in our first year of business. Our goal is to achieve “3-sigma performance” by maintaining a high standard in customer sales. We are confident that our company can reach this level of performance with our organizational expertise and innovative product design. RRI believes our specialized, artisan-handcrafted paper helicopters will differentiate us from our competition and drive the Flight-On brand forward.

Our business currently targets the toy helicopter market by offering a competitive price without compromising on quality. Ultimately, we want our loyal customers to be satisfied with their purchase. Our potential market will include elementary aged kids in the United States from grades K-5. In 2012, there were 24.5 million students of this age group in the United States. Of these 24.5 million students, many will not require a paper helicopter for their current curriculum. If even 1/10 of these students want or need a paper helicopter, we will have an available market

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of 2.45 million students. Even with a market share of 5%, we could potentially sell to 122,500 students.

We project high sales potential, because more schools will be promoting STEM in elementary school. President Obama has mandated an increase in government programs to support science and technology, and has created the Committee on STEM Education. Together, they have created the STEM Innovation Proposal, which includes $170 million in funding to increase and sustain youth engagement in STEM. Because of this national push to encourage young students to pursue math and science, we predict the market will continue to grow.

1.1.1 Mission

Our mission is to design, test, sell, and distribute effective, lightweight, durable, and profitable Flight-On! helicopters (with appropriate launcher systems and packaging); resulting in a finished product, with negligible defects, optimized airborne time, sentimental value, and a commitment to quality.

1.1.2 Vision

Our vision is for our finished product to reach a growing audience of Flight-On aficionados willing to invest in our future product lines and corporate stock. To further this effort, we want our fans to use social media to let their friends know about our product, its environmentally friendly packaging and its 3-sigma performance to heighten demand for subsequent Flight-On! designs and redesigns.

1.1.3 Values

Our corporate culture at RRI is best defined as cooperative, interdependent, and results-oriented. Our team of engineers strives to achieve greatness in product design, development, testing, sales and distribution of our Flight-On! products to our esteemed clientele. Our operations are open to peer-review, optimization, and innovative training initiatives.

1.2 Applications

Robust Rotorcraft Industries has effectively created a product line which will conform to all specifications and requirements that our prospective customers would like to see in a quality paper helicopter. Every Flight-On! is created by a USC expert, meaning each product goes through necessary due diligence. Our company will also be providing a launch system with every paper helicopter. (This easy-to-assemble add-on will allow users to reliably launch and seamlessly track the flight trajectory of a Flight-On! unit.) We believe this service will further separate us from the rest of the market. Regarding the design of the product, we will carefully adhere to certain standards. These requirements include: a helicopter mass of less than 30 grams, a flight duration between 2 and 10 seconds when dropped from a height of 5 feet, and a landing point within 1 foot of a desired target. Therefore, Flight-On will last 20 flights while still meeting the above performance specifications. Our completed product includes durable packaging ensuring that the customer will receive both the helicopter and the launch system in perfect condition.

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2 Normative References

The following referenced quality manual was utilized as a guideline for indexing, structure, organization, and content-based integrity for RRI’s quality manual.

ISO 9000:2008

3 Terms and Definitions

Robust Rotorcraft Industries (RRI): Engineering firm overseeing operations of Flight-On! projects.

Flight-On!: RRI product (helicopter, launcher system, and packaging).

Launcher System: Elements that when assembled can effectively launch Flight-On!

Board of Directors: Founding members of RRI with management positions associated with significant operations facets of the company

Company operations: Product financing, product marketing, product planning, product designing, product testing, product quality control, product packaging, product sales, product delivery, product returns, product feedback

Human Resources Manager (Zain Bokhari): This individual is responsible for assigning tasks and micromanaging human resources at all stages of company operations. This includes, but is not limited to, initial hiring and selection of engineers, promotion of engineers, maintaining corporate values, reviewing employee and customer feedback, etc.

Financial Manager (Fu-Li Lin): This individual is responsible for documenting, tracking and allocating finances at all stages of company operations. This includes, but is not limited to, initial investment record creation, investor outreach, corporate stock and tax management, document control with updated records, sales estimates, salary estimates, and pricing estimates, and marketing costs, etc.

Marketing Manager (Shahryar Soha): This individual is responsible for marketing products using radio, print, online, and social media resources at early stages of company operations: product marketing, product planning. This includes, but is not limited to, mapping out marketing costs, distributing marketing resources, attending community outreach events, appearing at USC marketing events, etc.

Manufacturing Manager (Katie Rose Beach): This individual is responsible for manufacturing procedures at intermediate stages of company operations: product designing, product planning, product testing, product packaging, and product delivery. This includes, but is not limited to, approving process maps of company operations, approving final designs for production and distribution, overseeing production and testing procedures, ensuring quality delivery of products, etc.

Page 9: ISE 527 Team 5 ISO Quality Manual

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Page 10: ISE 527 Team 5 ISO Quality Manual

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Figure 1. The Quality Management System of Robust Rotorcraft Industries

The Quality Management System shall

● be established based upon the mission, vision and value of Robust Rotorcraft Industries and adhere with these central philosophies,

● determine a business strategy to extend what its mission and vision intend to achieve, ● define customer requirements based on the business strategy, ● design a production process which produces products that meet the customer requirements, ● monitor and control product quality through reliable validation test to ensure the achievement

of critical specifications, ● build a trustworthy delivery process to comprehend the product service thoroughly, ● develop customer feedback mechanism to collect customer satisfaction result derived from

the entire service process, ● continue to improve and revise the business strategy to best satisfy the customer, ● apply quality tools, which include Potential Failure Mode & Effect Analysis, Quality

Function Deployment, and Statistical Process Control, to build base as the fundamental for the entire management system.

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4.2 Documentation requirements

4.2.1 General

The Quality Management System includes:

● Robust Rotorcraft Industries quality policy with documented statements and quality objectives,

● Robust Rotorcraft Industries Quality Manual, ● product and service process procedures and records required by the standards, ● documents, including records and files describing the planning, operation and control of the

processes.

4.2.2 Quality manual

Robust Rotorcraft Industries provides the Quality Manual, which describes the quality management system in detail. The content of the Quality Manual is comprised of:

● the scope of the Quality Management System ● the documented procedures built for the Quality Management System ● the description of interaction between the processes of the Quality Management System

The maintenance of the change and review record of Quality Manual is detailed in the Appendix A: form 4221.

4.2.3 Control of documents

Robust Rotorcraft Industries has established a system to manage documents. The purpose of this system is to:

● approve documents for adequacy prior to issue ● review and update documents if necessary ● identify the changes in the current revision status of documents ● ensure to update relevant versions of applicable documents ● keep documents legible and readily identifiable ● ensure to control obsolete documents to prevent the unintended use ● identify and control external documents

The detailed procedure of the control of documents is included in the Appendix A: form 4231.

4.2.4 Control of records

Robust Rotorcraft Industries has been collecting and maintaining records as evidence of conformity to requirements and of the effective operation of the quality management system. RRI has also established a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

The detailed procedure of the control of records is included in the Appendix A: form 4241.

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5 Management Responsibility

5.1 Management Commitment The Flight On! executive management is committed to developing and producing quality paper helicopter products. In order to continually improve quality effectiveness, top management will implement a quality management system. These steps will be established and maintained by the QC Manager, Christopher Gordon, but will be supported by all members of the management team. The Flight On! Management Team’s commitment to continually improving quality will be evidenced in the following action plans:

communicating to the org how important it is to meet all requirements for: o customer o regulations o statutory

establish quality policy

ensure that quality objectives are established

conduct management reviews

ensure the availability of resources

5.2 Customer Focus Customer satisfaction is a top priority at Flight On! and top management ensures that customer all customer requirements are determined through market research and feedback. We aim to enhance customer satisfaction by delivering an ever improving product. Each Flight-On! Helicopter is rigorously tested to ensure that all key characteristics will be achieved in each and every single product. These key characteristics include the weight of the helicopter, the flight duration, the survival rate, the distance between the drop point and the target, accurate assembly, and that all parts are placed inside the shipping box. In an effort to constantly enhance customer satisfaction, external and internal customer will be surveyed every quarter. All customers will be invited to complete a survey in exchange for a 15% off coupon. Their responses will be tabulated, analyzed, and saved in the company database. This will allow top management to quickly respond to the ever evolving customer requirements.

5.3 Quality Policy The top management at Flight On! is committed to continuously improving the quality of the organization, through the implementation of a quality policy. After establishing the quality framework, the quality objectives will be reviewed on a quarterly basis. Top management will hold a strategic planning meeting to track progress and determine where we want to be in the coming months. Part of this strategic planning meeting is confirming that we comply with all requirements and addressing the effectiveness of the quality management system and areas for improvement. The current quality policy will be reviewed for continuing suitability and communicated with the rest of the organization through notices and training.

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Quality will be reviewed through every stage of the manufacturing process. Each material, including the paper and paper clips, will be inspected upon procurement to verify that it meets with the requirements. The initial shipment will be judged on appearance and condition to provide a baseline for later inspections. Results from all inspections will be tabulated and sent to an advisory board for further review. During the manufacturing and assembly of the helicopters, quality will be maintained through weekly training sessions for both new and experienced employees. The purpose of these workshops is to encourage creativity, mistake-proofing, and learning. Assemblers’ techniques will be evaluated and improved to reduce the Flight On! production speed while minimizing errors. The Quality Control Manager will attend these sessions and record artisans’ ideas on how the Flight On! can be modified in future builds. He will also record data on manufacturing times, manufacturing steps, and manufacturing precision. We want to know if there is any variation from artisan to artisan and if there can be improvements. After each workshop, the QC Manager will present any findings to the advisory board, so they can continually improve the effectiveness of the quality management system. In terms of packaging requirements, specialists will test the cushioning and damage resistance of the boxes. The specialist will also record the contents of each package on the server. A liaison has been appointed to work with the delivery service, and he will maintain the tracking information for packages and work customer service for deliveries.

All employees are required to complete quality training, so that the entire organization understands our commitment to quality. The training will be regulated by the human resources department, so that top management can verify that all training modules are up to date and that employees have completed all applicable modules. Audits will be performed to verify that employees are correctly trained and are adhering to manufacturing processes.

5.4 Planning

5.4.1 Quality Objectives The quality objectives implemented by Flight On! Executive management will facilitate conformance to both customer and regulatory requirements, as well as aid in the deployment and improvement of the quality management system. These objectives are measurable so that the metrics can be reviewed on a quarterly basis for areas of improvement. They are also consistent with the quality policy as described in Section 5.3.

Consistently meet or exceed the requirements and expectations of our customers

Actively Pursue ever improving quality through controlled processes

Implement and Track Employee Training and Development

Reduce non-conformances on the Flight On! Helicopter Assembly line from 15% to 5%

Obtain 95% on time deliveries

Improve profitability and customer value

Obtain and maintain ISO 9000 Registration by January 5, 2015

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5.4.2 Quality management system planning Quality Management System Planning is essential to the organization’s success in satisfying customers. Top management will create an action plan to guide employees in the quality policies as they evolve and change. As stated in Section 5.3 Top management shall hold quarterly strategic planning meetings. The Quality Management system planning shall ensure that:

The QMS Plan will meet the requirements outlined in section 4.1 as well as the quality objectives.

The QMS will be maintained and updated quarterly to reflect any changes that have been planned or implemented.

5.5 Responsibility, authority, and communication

5.5.1 Responsibility and authority Top management, which includes the Flight On! board of directors, is comprised of the Flight On! CEO and the managers of the following departments: Manufacturing, Sales, Marketing, Human Resources, Quality Control, and Finances. The responsibilities of these functional roles are described in the table below.

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Functional Roles and Responsibilities

Functional Role Responsibilities

Manufacturing Manager

Planning Daily Activities Sequencing and Assigning work, Selecting proper equipment

and materials to meet or exceed customer requirements Deployment of lean manufacturing techniques Develop metrics, review and interpret data

Sales Manager Direct the distribution of products to customers Establish sales regions, quotas, and goals Develop strategies for efficient operation of the sales team Meet and exceed sales targets

Marketing Manager Set up focus groups to improve company products Develop pricing strategies Connect customers with products via social media

HR Manager Implement human resource policies Educate employees by facilitating training and development

programs Implement talent acquisition process to attract and retain high

performing talent

QC Manager Oversees the evaluation of the finished product for quality and reliability

Establish procedures for maintaining high standards of quality Organize companywide quality improvement efforts Implement and Maintain company quality system

Financial Manager Produce financial reports, cash-flow statements and profit projections

Develop strategies for long-term financial goals Providing and interpreting financial information Research factors influencing business performance

5.5.2 Management Representative Christopher Gordon, our Manager of Quality Control has been appointed as the responsible authority for the quality management system. In addition to his responsibilities as Quality control manager, Christopher will ensure the following:

Processes needed for the quality management system are established, implemented and maintained

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Performance of the quality management system and any necessary areas of improvement shall be reported to top management.

The promotion of awareness of customer requirements throughout the organization.

5.5.3 Internal Communication Formal communication regarding the Quality Management System will occur quarterly. These meetings will discuss the effectiveness of the quality management system. Top management is not limited to communicating during these regularly scheduled meetings. We encourage open lines of communication throughout the company and foster respect for one another’s opinions. In addition to the quarterly meetings, the organization will also participate in the following:

Management Review Meetings

Department Staff Meetings

All Hands Meetings

Internal Audits

In each of these meetings attendance will be taken, meeting minutes will be sent out, and action items will be documented.

5.6 Management review

5.6.1 General

Flight On! executive management will hold quarterly Quality Management Reviews to guarantee the continuing suitability, adequacy, and effectiveness of the quality management system. During these reviews, management will assess the information outlined in the Review Input, Section 5.6.2, and Review Output, Section 5.6.3, to determine opportunities for improvement. This information will also be reviewed for any necessary changes in the quality management system, including the quality policy and the quality objectives. The Management Reviews will be documented using form 513, included in the appendix, and will be saved on the server for future use.

5.6.2 Review Input

The input to the Quality Management Review shall include, but is not limited to the following information. This information shall be recorded in Form 513: Management Review Input/Output.

Audit Results

Feedback from Customers

Performance of Processes and Product Compliance to Specifications

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Preventative/Corrective Action Status

Action Item Follow Up from Previous Management Reviews

Changes Affecting the Quality Management System

Improvement Recommendations

5.6.3 Review Output

The output to the Quality Management Review shall include, but is not limited to the following information. This information shall be recorded in Form 513: Management Review Input/Output. Output items will be assigned to the responsible functional business role for implementation and completion.

Quality Management System Effectiveness and Process Improvement

Customer Requirement Driven Product Improvements

Resources Needed

Related Documents

Appendix A: Form 513: Management Review Input/Output

6 Resource management

6.1 Provision of resources

Robust Rotorcraft Industries (RRI) is committed to achieving full customer satisfaction

through an effective quality management system. Implementing and maintaining such a quality management system requires qualified resources such as a dedicated human resource department, high quality infrastructure and a professional work environment. RRI’s goal is to provide sufficient resources and develop maintenance plans in order to provide, maintain and improve the required resources.

6.2 Human resources

6.2.1 General

The unique nature of the RRI’s final product, which is a handcrafted helicopter, requires personnel to perform flawlessly. Each employee can affect the product’s performance which represents the company’s overall quality. That is the reason why sufficient education, training, skills and experience are needed in order to satisfy all product requirements. RRI is committed to

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ensure the personnel’s competency by having selective employment system and continued training.

6.2.2 Competence, Training and Awareness Robust Rotorcraft Industries has developed a protocol to ensure personnel’s competency

a) Any open position in the company shall be advertised through appropriate job related websites and newspapers. A sufficient job description, detailed requirements and minimum qualifications shall be included in the job ad. The application has to be filled and submitted online.

b) All candidates will be selected based on their level of experience and education. The position will be filled by performing two interviews, one by the relevant work section and the other by human resource department. Candidates will be evaluated by the level of their technical competency, commitment and determination.

c) After the employment procedure, in the first three months of work, a comprehensive amount of training shall be provided for the new employee. This training consists of both technical and ethical issues. At the end of this period, the new employee will be able to perform the basic job functions in a satisfying way, and he will also realize the importance of his activity and his influence on the company’s overall performance.

d) Periodic training sessions also will be provided for all employees in order to keep the personnel up-to-date with the latest changes. By participating in these sessions employees gain more knowledge of their own field of work, as well as other sections’ field of work, which can help them gain a broader understanding of the company’s functions.

e) Employees are required to take periodic tests based on their job field in order to evaluate the training session’s effectiveness. In case ones performance doesn’t satisfy the relevant department, extra individual training sessions will be provided.

f) RRI maintains an appropriate database of all employees and their level of competency as well as other factors.

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6.3 Infrastructure

The RRI team will continuously work on determining the necessary infrastructure needed for the processes, as well as developing maintenance plans in order to maintain the desired level of quality. The company’s main facility is in Gardena, California, which will house all operations. There are periodic maintenance plans for repairing and improving the facility as needed. The company also possesses the necessary process equipment. Each piece of equipment must perform within certain limits of precision, which means developing calibration plans and repair plans will be necessary. Maintenance plans for both the equipment and the facility will be conducted by the manufacturing manager, and the result will be reviewed by all RRI team members.

In order to make internal and external communication and data exchange as easy and as fast as possible, appropriate Management Information Systems have been configured and implemented. RRI has decided to buy the SAP ERP system designed for small businesses in order to avoid any error or delay in communication. Periodic reports will be taken out of this system in order to assess the company’s overall performance.

6.4 Work environment

The main substance in producing helicopters at RRI is paper, which requires a special work environment. High temperature and high humidity can damage both the raw material and the final product. RRI’s plan is to measure and manage the work environment on a daily basis in order to maintain the product’s quality, in turn, leading to customer’s satisfaction. The manufacturing manager responsible for all maintenance will check the humidity and the temperature of the work environment 3 times per shift.

RRI is also committed to providing a safe work environment for all employees. It has been decided to control the facility’s safety and cleanness by developing a 5S approach which can help the employees manage the facilities safely, as well as making the work processes more efficient. There will be special training classes for all employees in order to introduce and clarify the principles of 5S and the steps to conduct 5S in our facility.

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RRI will work to enhance the efficiency as well as the safety of its workplaces by regular activities such as classifying and cleaning through 5s. In order to confirm the 5s principles are being followed thoroughly in all departments, all quality control managers shall observe and control each employee’s performances regarding 5s.

7 Product Realization

Product realization describes the effort that Robust Rotorcraft Industries has set forth in order innovate, create, and deliver the paper helicopters to the customers as well as adhere to QMS. To ensure that product realization is accomplished with the guidelines set forth earlier, metrics must be recognized, calculated, and verified for in depth analysis.

7.1 Planning of Product Realization

In terms of quality objectives and requirements for the product, the team has mandatory rules for each helicopter that we create. We require the following characteristics for each product:

The weight of the helicopter must be 15 grams, with a tolerance of 0.5 grams The flight duration must be 4 seconds, with a tolerance of 0.5 seconds The number of survivals per helicopter must be 25 instances, with a tolerance of 1 instance

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The distance between the drop point and the target must be 0.4 feet, with a tolerance of 0.2 feet

The assembly process per product must have a success rate of 100%, ensuring quality products

As a result of these requirements, documentation must be taken to ensure that each characteristic is fulfilled. This documentation can be found in the form RRI-45, contained in the Appendix of this manual.

With the introduction of any product, the marketing team, the quality control team, and the manufacturing team must verify that the product meets the specifications we listed earlier. Multiple tests will be conducted within the company before considering the product for further manufacturing.

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

In regards to requirements specified by the customer, we were able to reach out to potential customers and get some insight on what features they would want from our product. This process involved bringing in potential customers to our facility and getting their input. We were also able to offer surveys, which allowed us to focus in on certain characteristics of our products. The customers listed the following:

The helicopter mass must be less than 30 grams The helicopter should be comprised of one or more parts The helicopter must be hand-crafted The complete delivered product must include the helicopter, the launch system, and

packaging The helicopter would drop within 1 foot of a target The flight duration would be between 2 and 10 seconds The helicopter must survive at least 20 flights The product must have a minimal standard deviation for its flight time

With these requirements in mind, the team at RRI wanted to ensure we would capture any other additional requirements. We determined it would be most suitable to define these requirements during our creative processes, as we develop a better sense of what our product should include. This would be influenced by the planning stages for product realization, as described in Section 7.1.

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7.2.2 Review of Requirements Related to the Product

Once we have collected all of the requirements provided by both external and internal customers, top management will review the appropriateness of each requirement. This will involve a formal process and require a meeting of the executives. This meeting will be a crucial step toward the production of our helicopter, and without careful deliberation, there is potential that we could provide a product that customers would not desire. This would ultimately hurt our company greatly and cause immediate reevaluation. Within this meeting, the following topics will be discussed:

All executives must come to an agreement on which requirements are relevant to our product. Within this definition of requirements, an order of priority must also be established. This will give the company guidance on what our primary goals are during production. With this prioritization, we can better align our business to achieve such goals.

Any differences between updated requirements must be reviewed appropriately, with the executives reviewing the new information appropriately. If necessary, an additional requirements review will be held in order to address such issues. Within this additional meeting, documents must be amended and associated personnel will be notified of the modifications in the requirements.

Finally, the executives must come to a consensus regarding the capability of the company. They must all agree upon the idea that RRI can fulfill the requirements that are outlined in section 7.2.1.

Any major outcomes or calls to action within these meetings must be documented appropriately using form 722. Within this form, there will be clear notification when this meeting took place, in the case of a second meeting.

7.2.3 Customer Communication

In order to determine the most effective methods of communicating with external customers, the Marketing team at RRI has conducted research and used benchmarking to observe strategies from other companies. Based off this, the team was able to devise the following strategies for each of our key areas:

For product information, we will announce a press release through our website which will inform customers of the changes in product information. This information will also be emailed to customers who have provided such information to our website.

For inquiries, we will offer a customer service line which will be available 24 hours a day, 7 days a week. This will require customer service centers to be established in other parts of the world, so that we can satisfy this availability. We will also offer a form on our website that customers can fill out. We will then contact them through either email or phone and answer their questions directly.

For customer feedback, we will include a short survey form with each one of our products. Customers will then have the option to fill it out and mail it to our company free of charge. If the customer provides us their email, we can also send them a link to an online survey, where they can provide their comments and complaints. The customer service line would also be able to support this aspect.

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7.3 Design and Development

Design and Development is an integral process within Product Realization. At this stage, our requirements determined in Section 7.2.2 come to fruition. The team translates these ideas into specifications for our product, detailing what our product will be and how it will fulfill the determined requirements. As requirements are altered and added to our product, the departments responsible must maintain appropriate documentation to account for such changes.

7.3.1 Design and Development Planning

In order to properly execute design and development, these processes must be planned appropriately. Along with this planning, quality control shall determine how to best control these processes to maintain consistency and promote high quality. The design and development stages are the following:

Collection of data relevant to placed requirements Ordering of raw materials Initial construction of product Revisions of design to improve alignment with specifications Finals construction of product Quality check of products to ensure lack of defects Shipment and delivery of final product to the customer

Each of these stages are crucial in that we must always innovate and improve our processes. With these in mind, there must be appropriate review, verification, and validation for each of these stages. Failure to ensure that each stage is checked may result in a deficiency in quality aspects. This review, verification, and validation process will take place at the end of our manufacturing process. Those involved with quality control will verify that each product adheres to our specifications and is acceptable to send to our customers. In relation to shipment and delivery, our products will be verified by those responsible for the transportation.

Our manufacturing and quality control departments will be responsible for maintaining the design specifications that will be determined within this phase. Manufacturing will ensure that each product has a design that will fulfill our set specifications. The quality control department will maintain any associated documentation necessary in regards to design and development. With any changes for design and development, the product must be retested and validated before we can make the product available to the external customer.

7.3.2 Design and Development Inputs

Inputs relating to the determined product requirements will be defined within the scope of the Design and Development plan. All inputs will be reviewed to verify that they will fulfill the

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requirements. Any inputs that may appear to be unclear will be resolved in a timely manner. The quality control department will be responsible for reviewing these inputs.

Inputs would include the following:

Functional requirements

Performance requirements

Additional information from prior similar products

Special packaging requirements

Environmental and safety requirements applicable to the disposal of materials, recycling, and potential safety hazards that may exist

Additional requirements

Any additional requirements must be presented to the executive board for approval. The design inputs will maintained as a quality record using the form 732.

7.3.3 Design and Development Outputs

Outputs relating to Design and Development must be properly recorded in adherence with the planning phase in Section 7.3.1. All outputs must be compared to the inputs that are documented in the form 732. These outputs must be approved prior to release to the public.

The outputs would include the following:

Proper documentation that verifies functional and performance requirements have been met

Evidence related to prior products is made available to the involved departments

Documentation that regulations for our product have been met

Documentation for purchasing, production and services

Confirmation that we are adhering to environmental and safety standards

Any additional documentation as deemed necessary

7.3.4 Design and Development Review

The review process is a critical procedure within the entire product realization process. Effective review will ensure that we are delivering a quality product to the public. In other words, the review process will assure the company that we are fulfilling all of the requirements developed. The quality control department will be responsible for this review process. However, representatives from the manufacturing department may also assist with each review. Each design review requires that a full record of meetings be maintained using the form 734.

The design review process includes:

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Confirm that all identified requirements have proper documentation and have been properly approved

Every feature of the design can successfully fulfill the requirements If any problems should arise, top management from quality control and manufacturing will

handle the matter in a timely manner

The design review process can be adjusted, depending on the scope of work that is involved. It is imperative that we review our design and development to ensure our product has top quality.

7.3.5 Design and Development Verification

As the process for product realization gets closer to completion, it is crucial that the company verifies our final product has fulfilled all requirements and specifications determined during the planning phase and modified throughout. All verification practices are conducted with the intention of ensuring that the outputs of the design and development process achieve the input requirements. Form 735 will be used during this process for proper documentation and to ensure there is proper approval before this process can move onto the validation step.

7.3.6 Design and Development Validation

As the process for product realization gets closer to completion, it is crucial that the company validates our final product has fulfilled all requirements and specifications determined during the planning phase in Section 7.3.1 and modified throughout. All verification practices are conducted with the intention of ensuring that the resulting product and its associated design can achieve the input requirements. This validation must take place before any delivery or implementation takes place. Form 736 will be used during this process for proper documentation and to ensure there is proper approval before product realization can be considered complete.

7.3.7 Control of Design and Development Changes

The company must adhere to a particular protocol in cases of any proposal to change any aspect of the design and development phase. A proposal to change must be submitted properly to the Review Committee. This committee will comprise of top personnel from the quality control and manufacturing divisions within our company, since these divisions are directly associated with the processes in design and development.

Within this committee, the proposals will be presented and the committee will determine how the proposed change would affect the associated processes as well as the final product. Meetings for the Review Committee can take place at any stage that is deemed appropriate. Notes will be maintained for each meeting to keep record of any proposed change, the committee’s thoughts, and ultimately whether or not the proposal was approved.

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All committee members will be required to fill out form 737 upon completion of each meeting. This form will document the key points from the meeting and the ultimate result for the proposal.

7.4 Purchasing

7.4.1 Purchasing Process

The purchasing process for RRI is formalized and based off our experiences with other similar companies. It is required that all steps of the purchasing process are appropriately documented, in case of any auditing that may take place. The purchasing process is as follows:

Once we have defined our specific requirements, we must determine the scope of work that is required to fulfill these requirements. Once we have an appropriate scope of work, we can then determine the types of industries we can observe to procure this product.

After determining the potential suppliers, we must get verification from them that they have the capacity and time to provide us with such work. If this is not possible, we can reach out to other companies that will satisfy these conditions.

We will then send out a request for a quote on the work we are requiring, along with the appropriate documents necessary for the work. These documents would include drawings, specifications, and other similar information. Each respective supplier would create their quote based on this provided information and then send it to us within a certain time frame.

Once we have received a quote from each supplier of interest, we can next evaluate each supplier side by side. The form for this supplier evaluation can be found as form 741.

After evaluating each supplier in relation to each other, the team will determine which vendor can fulfill our requirements best. This vendor will be notified that they were selected, and this will result in an agreement to purchase.

This is the typical process we would use to determine who we should be purchasing from. There may be instances where we will need emergency purchases, in which case we would have to follow a quicker process. This process would be similar to the aforementioned process. This process would also involve routine inspections for verification that we are receiving a quality product. If there is a notable downward trend in quality, then we will reevaluate our existing supplier and search for other options.

7.4.2 Purchasing Information

During any transaction between RRI and a supplier, the following information must be provided along with the product information:

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Requirements for product approval

Requirements for procedures and processes in creating the product

Requirements for equipment used in the making of the product

Description of personnel that will be involved with the processes for the product

Information regarding the quality management system in place

Failure to provide any of this information may result in a cancellation of a purchase. Repeated offenses may result in a cancellation of a contract, resulting in another purchasing process to take place.

7.4.3 Verification of Purchased Product

As mentioned in section 7.4.1, routine inspections will be conducted to verify the quality of the products we get from our chosen supplier. The supplier will be notified of this, in order to ensure that we receive high quality products from them. The supplier will also be informed of our methods for verification, which will confirm that all standards are being met. If some products fail to meet the requirements that we have set forth, the supplier will be sent a warning regarding their failure to meet quality. If there are repeat offenses, action will be taken regarding our status with the supplier.

Sample testing will be the main practice for our verification process, an appropriate method that will spot check the products we receive. If needed, RRI will provide the associated documents for our verification practices.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

All production processes will be controlled as per Section 4.1 and Section 7.1. The quality plan includes controls for production and service activities. Controlled conditions shall include:

What is being made as per information describing the characteristics of the product How it has to be made and in what sequence as explained in the available work instructions When it has to be made as per schedule What production equipment to use What monitoring and measurement devices to use What to inspect and when When the product will be released and delivered What services to provide after delivery What is required to be documented

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The quality plans will be reviewed when needed, at a minimum quarterly, for changes in product specifications or process parameters. All information will be documented and available for all to access. In addition, process control documents will be made available prior to production including work instructions and inspection instructions. Performance indicators shall be tracked and documented in order to help reduce variation and improve production processes.

7.5.2 Validation of Processes for Production and Service Provision

Validation shall be required for any product that cannot be verified without damage or destruction. The deficiencies will not become apparent until the product has been used or delivered. The quality of these products shall be verified through capability studies, which will demonstrate Flight On!’s ability to meet planned results. The validation procedures shall be documented and records will be maintained to prove our capabilities during audits. Any changes will be approved by a Validation Review Board. They will also determine whether the process must be revalidated. Quality plans will include validation controls used to achieve capable and consistent processes. The necessary arrangements for the following processes shall be defined in the quality plans:

Specific production and testing methods Qualification of equipment and materials Verification of personnel competency Defined criteria for review and approval of the processes Documentation Requirements Revalidation, when mandated by Validation Review Board

Process validation documentation will be recorded using form 752: Validation Review Checklist and maintained on the server to ensure quality products and services.

7.5.3 Identification and Traceability

RRI offers the highest in quality when it comes to product realization from order input to product delivery. Our engineers thoroughly identify if each component of our helicopters, launcher systems, and packaging meets our esteemed standards. To maintain traceability in our records, each part that we design and/or utilize is branded a specific seven-digit serial number based on its function. The first three digits of the serial number will signify the order number, the fourth digit will be the part class, and the last three digits will signify the part index. (This information can be found in form 753).

7.5.4 Customer Property

RRI values our customers and their property and information. We seek to use provided logistics to meet our customers’ demands, requirements, and requests with utmost expediency

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while maintaining necessary security and prevention of identity theft and fraud (as seen in form 754). In the event that provided logistics are inadequate or deemed unsuitable use, our team of experts with act swiftly to work with our customers to rectify the issue. In the event of missing/damaged information or property, RRI will take note in our records of the issue, order the appropriate replacement, and contact the department responsible to undergo an internal quality review.

7.5.5 Preservation of Product

RRI maintains integrity in entire product and individual part preservation to ensure our customers receive the best possible product conforming to optimal specifications. Our preservation process includes the aforementioned order identification and traceability quality measure, internal design reviews based on past customer feedback requests, appropriate handling of the product to ensure safe transport during manufacturing processes, effective packaging of products to minimize damage from externalities, and secure storage locations to prevent misplacement or damage to completed deliverables waiting to be shipped.

7.6 Control of Monitoring and Measuring Equipment

Robust Rotorcraft Industries is committed to minimize the non-conformities within organization by establishing standards for Controlling the measurement and monitoring equipment. The quality Control department is responsible for defining suitable measurement systems, controlling and monitoring the system’s effectiveness and updating the system as needed.

In order to maintain the product’s performance through minimizing the dimensional variation, steel made models are being used as samples which are made with high precision using milling machines. The product shall be compared with the sample through the assembly period. Samples’ accuracy should be assessed twice a day at the beginning and end of working shifts by the Quality Control department. All samples have their unique ID and label, after each daily assessment, the results should be recorded and documented. Samples should always be kept in special boxed bought from the proving company to be protected from environment and physical damages. Non precise samples shall be gathered and sent back to the milling company to recalibrate. If the quality engineer finds non-conformity in a sample at the end of the working shift, he shall notify the manufacturing manager. Affected products shall be retested with new sample in order to prevent external complaints.

Another measurement device which requires inspection and controlling is the stop watch. The stopwatch is being used by RRI in order to assess the helicopters flight duration. The stopwatch has to be tested every time before usage. The operator shall determine the precision of the equipment by comparing the result with another stopwatch. In this calibration method the operator holds two stopwatches in his hands and starts them at the same time. After a few seconds he will stop both of them and compare the results. If there is any nonconformity, he will exchange one stopwatch with another and repeat the experiment. He shall continue this process

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to identify the non-precise stopwatch. All stopwatches have their unique ID and all information regarding their performance shall be recorded and documented. Stopwatches should be always kept at a non-humid environment and be protected from physical damage. Faulty stopwatches shall be gathered and sent to the provider in order to be recalibrated.

8 Measurement, Analysis and Improvement

8.1 General

Robust Rotorcraft shall take all the necessary steps to ensure that the customers receive the best paper helicopters, meeting all quality requirements. To achieve this target, Robust Rotorcraft quality plans are used to implement the monitoring, improvement, measuring, and analysis of processes that:

Prove conformity to service and customer requirements

Prove conformity of the quality management system

Ensure continuous improvement of the quality management system

This process would include the identification of all applicable and appropriate methods, as well as statistical techniques.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

Customer satisfaction is our top priority at Robust Rotorcraft and is a key performance metric in both design and service. Robust Rotorcraft shall incorporate customer inputs into the design and engineering of the product to ensure customer requirements are not just met, but exceeded. The methods of determining customer satisfaction include: customer surveys, warranty claims, business sales analysis, and customer complaints/compliments.

8.2.2 Internal Audit - documented procedure (form 8221), audit results (form 8222)

Internal quality system audits are conducted to ensure that Robust Rotorcraft quality system complies with specified requirements and is implemented effectively. Robust Rotorcraft will conduct internal audits at every 4 months to ensure the quality management system

a) Is in alignment with the requirements of the International Standard and Robust Rotorcraft’s quality management requirements

b) Is being used effectively and continually

An audit program will be implemented in target focused process areas. The scope, frequency, and methods of audit are established in the Internal Audit procedure. The auditor

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shall maintain impartiality during the audit process, and auditors will not audit their own work. It is required that at least one audit member has completed the necessary audit training.

All internal audit results are submitted and reviewed to the personnel having responsibility in the area audited. The area being audited shall have corrective actions established, which can be implemented immediately to extinguish any detected nonconformities found in the audit. The results of the internal audits shall be documented and maintained.

8.2.3 Monitoring and Measurement of Processes

Robust Rotorcraft processes are continually monitored and measured to ensure that customer requirements are met in every aspect. The processes are monitored to ensure their intended purpose is still being used correctly and effectively. When planned results are not achieved, correction and corrective action is taken to ensure conformity of the product.

Each department is responsible for selecting the methods of monitoring and measuring of the planned process results. All employees can give any suggestion regarding new techniques for monitoring and measurement of the quality management system processes. Measurement quality includes accuracy, cost reduction, and reliability.

8.2.4 Monitoring and Measurement of Product - (form 824)

Robust Rotorcraft monitors and measures all characteristics of the paper helicopters and production tools to ensure all requirements have been satisfied. This is done by calibration of equipment, inspection of tools, and random test sampling of product at separate points in production. Inspection results are documented and records must indicate the authorizing person who is in charge of releasing products. If a product or equipment fails inspection, the actions defined in the correction procedures are followed and nonconformities are noted. The unqualified material is not to be used until it has passed the appropriate inspections.

8.3 Control of Nonconforming Product - (form 831)

Robust Rotorcraft ensures that if any service or part is suspected of being non-conforming, it will be noted and prevented from the manufacturing environment and placed in inspection area to be decided if it should be fixed, reworked to disposal. Only after the inspection is passed, will the part(s) be returned back to the manufacturing environment. Robust Rotorcraft has processes that will define the control of nonconforming product procedures. We follow appropriate actions that address the potential effects of nonconformity when it is identified post installation. These documents are included in the form 831 and deal with the identification, documentation, evaluation, and disposition.

To ensure the nonconformity, control of nonconforming service report is addressed and does not affect the rest of the manufacturing and assembly processes.

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8.4 Analysis of Data

Robust Rotorcraft is in charge of collecting and analyzing data to gauge the effectiveness of quality management system and determine root causes of quality and customer satisfaction variance. The data is collected from sources that will be determined. Robust Rotorcraft will maintain data from customers based on feedback return rate, as well as customer satisfaction. The error and defects of product is also an important data source to improve the quality. Data analysis will provide data from:

a) Customer Satisfaction

b) Conformity to Quality Standard

c) Supplier Relationship

d) Manufacturing defects

e) Conformity to Customer Requirements

f) Identification of the characteristics and trends of quality performance

8.5 Improvement

8.5.1 Continual Improvement

Robust Rotorcraft will continually work to improve the quality and effectiveness of both their products, services, as well as the quality management system. The methods for continually improving include: analysis of data, quality audits, corrective and preventative actions, employees satisfaction, quality standard and constantly searching for new industry trends and technology. Each employee shall get trained in each month to improve the skills and efficiency. Process audits will be implemented every four months to ensure that all of the processes are carried out with high efficiency.

8.5.2 Corrective Action - documented procedure (form 8521), corrective action results (form 8522)

Robust Rotorcraft shall take appropriate action to ensure errors and defects do not occur. Therefore corrective actions are taken to eliminate the nonconformities from the processes.

Robust Rotorcraft established a documented procedure to define requirements for:

Identifying and reviewing nonconformities

Determining the causes of nonconformities

Evaluating the need for action to ensure that nonconformities will not recur

Determining and implementing the actions needed

Recording and Analyzing the corrective actions taken to gauge their effectiveness

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8.5.3 Preventive Action

Robust Rotorcraft implements preventative actions to prevent and eliminate potential sources of nonconformities before their initial occurrence. To determine areas of potential nonconformities, Robust Rotorcraft conducts several internal and external audits along with customer complaints to formulate the necessary preventative actions. When a potential or realized source of nonconformity is found, management shall execute the appropriate action. These actions are recorded and documented.

Robust Rotorcraft established a documented procedure to define requirements for:

Identifying potential nonconformities and their causes

Evaluating the need for preventative actions

Determining appropriate preventative actions to eliminate the nonconformity

Recording the results of actions executed

Analyzing the actions taken to gauge their effectiveness

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APPENDIX A: ASSOCIATED FORMS Document:

Robust Rotorcraft Industries – Quality Manual

Revision:

12/02/2014

Page:

30/40

ROBUST ROTOCRAFT INDUSTRIES

TITLE: Quality Manual DATE:12/02/2014

FORM NO: 4221 PAGE NO: 1

CHANGE AND REVIEW RECORDS

The Quality Manual is reviewed semiannually to ensure the accordance with the quality policy all the time. The following table records the review and change records of the Quality Manual.

Change/

review date

Page number

Purpose Content Owner Manager signature

Manager signature date

Document:

Robust Rotorcraft Industries – Quality Manual

Revision:

12/02/2014

Page:

30/40

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ROBUST ROTOCRAFT INDUSTRIES

PROCEDURE FOR: Control of documents

DATE:12/02/2014

FORM NO: 4231 PAGE NO: 1

PURPOSE

Documented procedure is to control document approval prior to issue, review, update documents, ensure to identify changes and current revision status of documents, and ensure the up-to-date versions of documents are in use.

SCOPE

This procedure applies to all controlled documents in the quality management system, and includes the following categories of documents:

Quality Manual procedures work instructions record formats

RESPONSIBILITY

It is the responsibility of the document change owner to propose the change and update the related documents.

It is the responsibility of the document initial owner to create a new document.

It is the responsibility of the Factory Change Control Board to review and decide the change proposal’s approval or disapproval.

It is the responsibility of the manager to check and sign for the updated or new documents and then announce in the public documentation system.

PROCEDURE

The following process map identifies steps used to control documents.

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Document:

Robust Rotorcraft Industries – Quality Manual

Revision:

12/02/2014

Page:

30/40

ROBUST ROTOCRAFT INDUSTRIES

PROCEDURE FOR: Control of documents

DATE:12/02/2014

FORM NO: 4231 PAGE NO: 2

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Document:

Robust Rotorcraft Industries – Quality Manual

Revision:

12/02/2014

Page:

30/40

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ROBUST ROTOCRAFT INDUSTRIES

PROCEDURE FOR: Control of records

DATE:12/02/2014

FORM NO: 4241 PAGE NO: 1

PURPOSE

Records are established and maintained to provide evidence of conformity to requirements and the effective operation of the Quality Management System. The quality records should be legible, readily identifiable and retrievable. This procedure defines the controls needed for the identification, storage, protection, retrieval and disposition of records.

SCOPE

This procedure applies to all quality records in the quality management system. The records are managed at the department level and facility level.

RESPONSIBILITY

It is the responsibility of the record owner to manage the records. It is the responsibility of the manager to review records. It is the responsibility of all employees to maintain records in a secured manner.

PROCEDURE

The following procedures define detailed steps of control of records in different categories.

Control records for identification Keep employee identification as the highest classified information Record the performance evaluation of employees

Control records for storage Hard copy of records is stored by the owner of the document records and put in

files in order Soft copy is stored in the on-line documentation system.

Document:

Robust Rotorcraft Industries – Quality

Revision:

12/02/2014

Page:

30/40

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Manual

ROBUST ROTOCRAFT INDUSTRIES

PROCEDURE FOR: Control of records

DATE:12/02/2014

FORM NO: 4241 PAGE NO: 2

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Control records for protection Employee ID is needed to confirm when entering to the documentation

system Employees are forbidden to send the classified document records out of

the company All the records are stored in a suitable environment to prevent from

deterioration, damage or loss Secure and backup records to ensure the availability of records

Control records for retrieval Only employees are allowed to retrieve records Employee ID is required to access the online documentation system

Control records for disposition Obsolete records are disposed of by the record owner The hardcopy of records for disposition should be completely destroyed The electronic files for disposition should be deleted forever

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Management Review Input/Output

Form 513

Project Name Date Submitted

Requested By Date Reply Due

Management Review Input:

No. Deliverable / Item Revised End Date Document Number

1 Audit Results:

2 Feedback from Customers

3 Process Performance & Product Conformity:

4 Preventative/Corrective Actions Status:

5 Action Item Follow Up from Previous Management Reviews:

6 Changes Affecting the Quality Management System:

7 Improvement Recommendations:

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Management Review Output:

No. Deliverable / Item Revised End Date Document Number

1 Quality Management System Effectiveness and Process Improvement:

2 Customer Requirement Driven Product Improvements:

3 Resources Needed:

Project Manager Approval:

Signature Title Date

Attendees:

Name Signature Department Extension

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Robust Rotorcraft Industries

Document: Employee skills (Post Employment)

Date:

Form No: 622a Page No: 1

Personal Information

Employee Name: Employee Number:

Phone Number: Education: Address:

Professional Information Department: Hire Date: Work Type: Supervisor:

Individual primary Trainings Course ID Instructor Date score Passed/Not Passed Note

1

2

3

4

5

Group Training

Course ID Instructor Date score Passed/Not Passed Note

1

2

3

4

5

Originated by: Date: Reviewed by: Date: Approved by: Date:

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No.123456789101112

1314151617181920

______________/_____________Determination of RequirementsReview of Requirements

Robust Rotorcraft IndustriesDocument: Planning Product Realization RecordForm No: 711

Date:

Item No: Description:Page No: 1

Complete By/ Completion DateProcess______________/_____________

______________/___________________________/___________________________/___________________________/___________________________/_____________

______________/___________________________/_____________

______________/___________________________/___________________________/___________________________/_____________

______________/___________________________/_____________

Monitoring and Contro

______________/___________________________/___________________________/___________________________/_____________

______________/_____________

Design and Development PlanningDesign and Development ExecutionDesign and Development ReviewDesign and Development VerificationDesign and Development Validation

Documentation and RecordInspectionFinal ReviewConformance and Compliance Records(Additional Process can be added if necessary)

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No. Yes No Comments12345678

910111213141516

QuestionThe requirements are being met

Robust Rotorcraft IndustriesDocument: Requirements Review Form Date:Form No: 722 Page No: 1Item No: Description:

Monitoring and Control

All customer needs are satisfiedRequirements do not overlapThere will be a follow up meeting

All requirements are understandableThe requirements are within specified scopeThe organization has the ability to meet requirements

(Additional Process can be added if necessary)

Department

Manufacturing

Quality Control

Marketing

Authorized Signature

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Design Requirement TypeFunctional

1234

Performance1234

Similar Products1234

Packaging1234

Safety1234

Other1234

Item No: Description:

Robust Rotorcraft IndustriesDocument: Requirements Inputs Date:Form No: 732 Page No: 1

Description Comments

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Responsible Department/EmployeeQuality ControlMarketingOther

Agenda ItemsReview of requirementsReview of documentation for requirementsReview of design characteristicsReview design specificationsMeasurementsAdditional Review Items

Changes, if any

Item No: Description:

Robust Rotorcraft IndustriesDocument: Design and Development Review Date:Form No: 734 Page No: 1

Name Signature

Status Comments

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No. Yes No Comments123456789

10

Item No: Description:

Robust Rotorcraft IndustriesDocument: Design and Development Verification Date:Form No: 735 Page No: 1

Have all materials been properly approved?Is the product in compliance with rules and regulations?Have all outlined processes been approved?

QuestionHave all requirements been properly authorized?

Other

Have all changes been accounted for?Other

Has the BOM been fully approved?Are outlined specifications achieved?Have all inspections been completed?

DepartmentManufacturingQuality Control

Authorized Signature

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No. Yes No Comments12345678910

Item No: Description:

Robust Rotorcraft IndustriesDocument: Design and Development Validation Date:Form No: 736 Page No: 1

Is the product functional?Does the product satisfy specifications?Are production processes repeatable for customer?

QuestionDoes this product satisfy the customer requirements?

Are quality records being maintained?OtherOther

Are there alternate options for production?Is customer input being accounted for?Are employees properly trained?

DepartmentManufacturingQuality Control

Authorized Signature

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Item No: Description:

Robust Rotorcraft IndustriesDocument: Proposal for Change Request Form Date:Form No: 737 Page No: 1

How will this change affect associated processes and the final product?

Please state proposed change and motivation for such change:

Quality Control

Notes from Review Committee Meeting:

Decision for Proposal:

Department Authorized SignatureManufacturing

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No.12345678910

Item No: Description:

Robust Rotorcraft IndustriesDocument: Supplier Evaluation Form Date:Form No: 741 Page No: 1

Is the pricing provided by the supplier sensible?Does the supplier have experience with similar products?Have we worked with this supplier previously?

Question Grade (1-10)Is the supplier ISO certified?Does the supplier have the necessary equipment for production?Does the supplier have the capability to perform this work?

Has the supplier provided samples and prototypes as needed?Will the supplier work closely with RRI to resolve any issues?

Can the supplier finish production within the given time frame?

Does the supplier fulfill the necessary rules and regulations?

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Validation Review Checklist

Form 752

Project Name Date Submitted

Requested By Date Reply Due

Validation Checklist:

No. Deliverable / Item Document Numbers

Expected Completion Date

1 Specific Production and Testing Methods

2 Qualification of Equipment and Materials

3 Verification of Personnel Competency

4 Defined Criteria for Review and Approval of Processes

5 Documentation Requirements

6 Revalidation

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Validation Review Board Approval:

Name Signature Department Extension

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Order Identification and Traceability Form 753

Order Number Date Submitted

Requested By Date Reply Due

Prepared By Supervised By

Order Details:

Part Name

Part Class Part Index Serial Number Document/Revision Number

Quality Review Board Approval:

Name Signature Department Extension

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Customer Property Review Form 754

Order Number Date Submitted

Requested By Date Reply Due

Prepared By Supervised By

Feedback Classification:

Feedback Type

Missing/Damaged Property (Y/N?)

Theft/Fraud Concerns (Y/N?)

Additional Comments on Product Condition and/or Product Quality

Part Serial Number (if applicable)

Quality Review Board Approval:

Name Signature Department Extension

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Internal Audit Form 8221

PURPOSE

The purpose of the procedure is to describe the internal audit process and to verify the effectiveness of the quality management system processes.

SCOPE

Robust Rotorcraft internal audits are planned, executed, and documented to conform with policies and procedures which determine the effectiveness of the quality management system by internal employees or external audit consultants. The responsibilities and instructions to conduct an internal audit are described in this procedure.

APPLICATION

All Robust Rotorcraft employees must follow this procedure.

DEFINITIONS

Internal Audit: A procedure designed to improve and measure the effectiveness of the organizations internal operations. It measures the effectiveness and adequacy of the quality management system processes by bringing a standard of established procedures.

Internal Auditor(s): qualified individual who conducts an internal audit. The internal auditor carries out the audit yet has no authority over the processes being audited.

RESPONSIBILITIES

Audit Manager:

· Management and monitoring of audit system metrics.

· Create bi-annual periodic plans and schedules.

· Provide direction to auditors to ensure quality and consistency is uniform through this procedure.

· Confirm internal auditors receive proper training.

· Oversee all aspects of the audit

· Maintain this procedure

Auditee:

· Working with Internal Auditors

· Provide guidelines and information as well as resources to achieve Internal Audit objectives

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· Perform appropriate corrective actions on any identified nonconformities.

Internal Auditor(s):

· Conducting internal audits in accordance with the International Standards and guidelines from audit committee.

· Produce a draft report and give it to management for review. Final report should include all management comments for the audit committee.

Management Representative:

· Authorize and approve internal audit schedule

· Review performance of audit system

· Provide feedback on draft internal audit report

· Implement results from internal audit into organizational activities.

PROCEDURE

1. Preparing Audit plan & schedule:

Preparation of the audit plan ensures that each function is audited minimum once in four months. The audit plan should be issued to the department heads and the auditors well in advance.

2. Preparing for the Audit:

a. The preparation of the audit starts with the issue of a standard checklist and the audit schedule shall be issued to the auditors in advance.

b. The auditors will co-ordinate with the auditee department heads for fixing up convenient timings for audit. For any clarification required in this process, the auditors shall seek the help of auditee department heads.

3. Conducting the Audit:

After fixing up the timing for the audit the auditor shall carry out the audit within 8 days of the decided date with the co-ordination of the auditee department head and auditor. The auditors should observe, examine and record objective evidence for the compliance with respect to the documented procedures and quality system requirements.

4. Preparation of Audit Observation Report & Non-conformity Report

a. After conducting audit, the auditors shall prepare audit observation report, where each point will be classified either as observation or nonconformity or potential nonconformity. A copy of the filled audit observation report should be sent to Manager immediately after completing the audit

b. The Auditors should prepare Nonconformity reports for all the non-conformity observed during the audit.

c. The auditee department head should identify the root cause for the non-conformity observed and take corrective actions to avoid recurrence of the non-conformities.

5. Closing the Non-conformity Report:

a. On implementing the corrective actions on or before the agreed date, the auditee department head should inform the auditors immediately.

b. Audits should verify with evidence that the corrective actions are implemented and entered it in the Non conformity report; the auditors then, shall send their copy to the manager immediately.

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c. A follow –up audit should be conducted by the auditor after a time period 10-15 days after carried out the corrective actions, to verify the effectiveness of the corrective actions.

Internal Audit Results

Form 8222

Document INTERNAL AUDIT RESULTS

Date

Action Type

Criteria Priority

Finding

Root Cause

Proposed Action

Due Date Task Assigned To

Completion Date

Task Verified By

Final Action

Action Effectivenes

s

Evaluation Date

Task Verified By

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Form 824

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Control of Nonconforming Product

Form 831

Purpose

The Nonconforming product procedure outlines and describes the control of identified nonconforming products. This procedure ensures identified nonconforming problems are addressed and do not occur again. This procedure ensures products are of a uniform standard quality and if not can be addressed promptly.

SCOPE

This procedure describes the steps, which must be taken in the case of an identified nonconforming product.

APPLICATION

All Robust Rotorcraft employees must follow this procedure.

DEFINITIONS

Nonconforming Product: a product which is identified as not conforming to established standards of quality and is at risk of causing service failure, risking customer safety and satisfaction.

RESPONSIBILITIES

Nonconforming Product Identifier:

· Identifies nonconforming products

· Gathers maximum information about issue

Department Manager:

· Instates Nonconforming Products Report

· Awareness of problem and implications

· Communication of product to employees

Corrective Action Owner:

· Establishing Corrective Action Plan

· Executing Corrective Action Plan

· Signs off on nonconforming Products Report

PROCEDURE

1. Identification of Nonconforming Product

a. Product failure is acknowledged and all products affected must be brought to management.

b. Relevant details acquired and documented.

2. Open Nonconforming product Report

a. Document known information

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b. Notify all involved parties that nonconforming product report has been opened

3. Assign Corrective Action ID number

a. Create Corrective Action Plan

b. Assign responsibilities to respective parties

4. Execute Corrective Action Plan

a. Carry out Corrective Action Plan

b. Evaluate and review Corrective Actions

c. Conform future nonconforming product risk for this product failure has been dissolved

5. Close Nonconforming Product Report

a. Ensure all additional information for Nonconforming Product Report has been gathered

b. Managerial sign off of Nonconforming Product Report

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Corrective Action

Form 8521

PURPOSE

The purpose of Robust Rotorcraft’s corrective action process is to address any identified nonconformities and systematically resolving the nonconformities by identifying their root causes. A corrective action plan should remove all root causes of nonconformities and improve service quality while reducing internal operating costs.

SCOPE

This procedure provides a guideline to be followed when Corrective Action is need.

APPLICATION

· All nonconforming processes and products

· All employees performing processes which have direct impact on service quality.

DEFINITIONS

Corrective Action: An action that addresses an identified nonconformity and identifies the root cause, solution, and implementation of the solution.

Effectiveness Reviewing: review to be completed after corrective action is completed which determines effectiveness.

Management Review Team: Management representative and representatives from each department include: Finance, Human Resources, Operations, and Sales.

Preventative Action: Action taken to ensure a process does not fail and operates as effectively as possible.

RESPONSIBILITIES

Department Manager:

· Assigning correct documents and implementation of corrective actions

· Present Corrective Action results to management.

· Oversee Corrective Action Plans to guarantee effectiveness of implementation.

Manager:

· Monthly revision of all corrective action plans implemented.

Corrective action Initiator

· Initiating Corrective Action Plan

· Identify potential root cause of nonconformity.

· Preparing corrective action results

PROCEDURE

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1. Nonconformity identified in process and corrective action initiated

2. Corrective procedure must be documented by personnel

3. The corrective action and nonconformance is reviewed to:

1. Identify nature of nonconformance

2. Identify potential root causes. I.e. Equipment failure or human error.

4. Potential root cause should be presented to management within 5 days of initialization of corrective action procedure.

5. Quality manager must evaluate the appropriate corrective action plan and present it.

6. After assumption is for potential cause is made, corrective action plan is executed to determine if it is indeed the root cause.

7. If assumption is incorrect, additional potential root cause must be identified. If assumption correct, process continues.

8. Process will be monitored to determine if Corrective Action Plan is extinguishing the nonconformity.

9. Process monitoring activities are documented on Corrective Action form

10. Corrective action taken should be reviewed and discussed in the management review.

12. Corrective action plan documentation is concluded and distributed to appropriate departments.

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Corrective Action Results

Form 8522