Quality Manual

ISE 527: Quality Management for
Engineers
Dr. Thomas C. Booth
Quality Manual, REV B
Due Date: November 29, 2016
Team #1
Mean Machine INC
Miaomiao Han
Kartik Sandeep Kulkarni
Rigved Karambelkar
Sarah Diehl
Vishaal Gopal

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Table 1: Record of Revisions
Revision Revised
Sections
Technical
Reason
Release
Signature
Date
A All Initial Release Vishaal Gopal 10/23/2016
B
1-3, 4.2.1-2.3,
5.3, 5.4, 5.5.1,
7.2.2, 7.3.1,
7.3.3, 7.4.1-4.2
Policy
improvements
Sarah Diehl 11/29/2016

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TABLE OF CONTENTS
1 Scope.....................................................................................................................................5
1.1 General...........................................................................................................................5
2 Normative References...........................................................................................................5
3 Terms and Definitions............................................................................................................5
4 Quality Management System.................................................................................................5
4.1 General Requirements ...................................................................................................5
4.2 Document Requirements................................................................................................6
4.2.1 General....................................................................................................................6
4.2.2 Quality Manual ........................................................................................................7
4.2.3 Control of Documents..............................................................................................7
4.2.4 Control of Records ..................................................................................................7
5 Management Responsibility...................................................................................................7
5.1 Management Commitment .............................................................................................7
5.2 Customer Focus .............................................................................................................8
5.3 Quality Policy..................................................................................................................8
5.4 Planning..........................................................................................................................8
5.4.1 Quality Objectives ...................................................................................................8
5.4.2 Quality Management System Planning ...................................................................8
5.5 Responsibility, Authority and Communication ................................................................9
5.5.1 Responsibility and Authority ....................................................................................9
5.5.2 Management Representative ................................................................................10
5.5.3 Internal Communication ........................................................................................10
5.6 Management Review....................................................................................................10
5.6.1 General..................................................................................................................10
5.6.2 Review Input..........................................................................................................11
5.6.3 Review Outputs.....................................................................................................11
6 Resource Management .......................................................................................................11
6.1 Provisions of Resources...............................................................................................11
6.2 Human Resources........................................................................................................11
6.2.1 General..................................................................................................................11
6.2.2 Competence, Awareness and Training .................................................................12
6.3 Infrastructure ................................................................................................................13
6.4 Work Environment ........................................................................................................13

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7 Product Realization..............................................................................................................13
7.1 Planning of Product Realization ...................................................................................13
7.2 Customer-Related Processes.......................................................................................14
7.2.1 Determination of Requirements.............................................................................14
7.2.2 Review of Requirements .......................................................................................14
7.2.3 Customer Communication.....................................................................................15
7.3 Design and Development .............................................................................................15
7.3.1 Planning ................................................................................................................15
7.3.2 Inputs.....................................................................................................................15
7.3.3 Outputs..................................................................................................................16
7.3.4 Review...................................................................................................................16
7.3.5 Verification.............................................................................................................16
7.3.6 Validation...............................................................................................................16
7.3.7 Control of Design and Development Changes ......................................................16
7.4 Purchasing....................................................................................................................17
7.4.1 Purchasing Process ..............................................................................................17
7.4.2 Purchasing Information .........................................................................................17
7.4.3 Verification of Purchased Product .........................................................................17
7.5 Production and Service Provision.................................................................................17
7.5.1 Control of Production and Service Provision.........................................................17
7.5.2 Validation of Processes.........................................................................................18
7.5.3 Identification and Traceability................................................................................18
7.5.4 Customer Property ................................................................................................18
7.5.5 Preservation of Product.........................................................................................18
7.6 Control of Monitoring and Measuring Equipment .........................................................18
8 Measurement, Analysis and Improvement ..........................................................................19
8.1 General.........................................................................................................................19
8.2 Monitoring and Measurement.......................................................................................19
8.2.1 Customer Satisfaction ...........................................................................................19
8.2.2 Internal Audit .........................................................................................................19
8.2.3 Monitoring and Measurement of Processes..........................................................19
8.2.4 Monitoring and Measurement of Product ..............................................................20
8.3 Control of Nonconforming Product ...............................................................................20
8.4 Analysis of Data............................................................................................................20
8.5 Improvement.................................................................................................................21

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8.5.1 Continual Improvement .........................................................................................21
8.5.2 Corrective Action...................................................................................................21
8.5.3 Preventive Action ..................................................................................................21
9 Appendix A: Documents ......................................................................................................22

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1 SCOPE
1.1 General
This document is the quality manual for Mean Machine Inc. (MMI) located in Gardena, Los
Angeles. MMI is a manufacturer of high quality model cars for use in pinewood derby style
competitions. Mean Machine Inc. is committed to providing its customers maximum satisfaction
by developing state of the art products. It plans to achieve this with a world class quality policy
and a quality management system, as outlined in this quality manual.
The Quality Management System Manual has been designed to meet the requirements of the
International Standard ISO 9001:2008. This document covers chapter wise each element
documented in ISO 9001:2008. This manual provides guidelines for various departments, which
includes process and documentation details for each stage of the product lifecycle.
The manual will be used as guide to train and ensure all management and employees are
following a standard process for developing, designing, purchasing, producing, and delivering a
product. The manual places emphasis on the importance of compliance to ISO 9001: 2008
standards. The expectation of this manual is to provide a document for achieving a stable, quality
product.
The Quality manual will be distributed to all departments within the organization as a controlled
copy. Approved suppliers and customers will receive an uncontrolled copy. Quality related
documents for all departments and functions are created based on the quality manual. The
Quality Manual will provide guideline to suppliers on the QMS, and the expectation is to adhere
to similar standards to ensure all supplied parts are meeting the same quality performance.
2 NORMATIVE REFERENCES
The following documentation was used as reference for creation of MMI’s Quality Manual:
ISO 9001:2008, Quality management systems.
3 TERMS AND DEFINITIONS
The terms and definitions used within this document are consistent with ISO 9000.
4 QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
To ensure that our products have a reliable and repeatable performance, a Quality Management
System (QMS) will be created and documented. The QMS will establish processes and
documentation for every step of the product lifecycle and will be based off of the ISO 9001-2008
standards. Although the QMS is written by the Quality Engineer and controlled by the Project
Manager, the organization encourages employee participation in suggesting process and product
improvement. By involving every member of the company, MMI hopes to encourage continuous
improvement that is not only driven by management, but also the people working with the product
on a daily basis.
MMI plans to achieve a reliable, repeatable, and continuously improving Quality Management
System by defining a set of processes. These processes include determining procurement
requirements, manufacturing and assembly plans, testing procedures, and shipping and handling

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processes and logistics. “P-410: QMS Process Map” in Appendix A shows the sequence of each
process and how they are connected together.
4.2 Document Requirements
4.2.1 General
The Quality Management System for MMI shall include the following:
● Quality policy,
● Quality objectives,
● Quality manual, and
● Mission, Vision, and Values.
Mission
Mean Machine Inc.’s mission is to provide custom built, quality cars to compete in a pinewood
derby style competition. Our company’s mission is to get things right the first time, every time.
Vision
MMI’s foundation is built on quality. We strive to achieve a 3 sigma performance level, which will
help facilitate in exceeding customer expectations. Our vision is to initially target the pinewood
derby competitions located near the Los Angeles, California area. Starting with a modest
production output per month, our plan is to consistently increase production rates as our market
expands. In the long term, MMI’s goal is to achieve a majority market share in California.
Values
● Exceed customer expectation on product quality and performance.
● Employee satisfaction leading to enhanced productivity.
● Safe work place with zero accident and 100% work ethics.
● Excellent supplier and customer relationship.
Quality Objectives
Mean Machine Inc. will produce pinewood cars which will travel a set distance over the course of
several runs. In addition to maintaining a consistent travel distance, MMI will focus on optimizing
speed and performance over bumpy terrain. Quality will be maintained by focusing on the
following objectives and initiatives:
● Through standardized processes and periodic training of its employees, the organization
plans to maintain exemplary quality standards in product performance and delivery.
● By optimizing speed and performance MMI will ensure it exceeds both external and
internal customer expectation.
● MMI will ensure the product delivered complies with our company’s quality standard and
also meets the Los Angeles Federal Rules and Regulations.
● Through extensive research and quality procedures Mean Machine Inc. shall develop
products with unique design features. These design features will enhance product
capability to ride smoothly over bumpy terrain.
● Benchmarking initiatives will be used as a means of continuous research & development.
The goal of benchmarking is to focus on continuously improving our product and
processes.

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● The management of Mean Machine Inc. will ensure there is alignment of the quality
policies and procedures with the business objectives. All quality and business objectives
will be communicated company-wide on a regular basis. This is to ensure MMI is
maintaining a culture of quality and continuous improvement.
The Quality policies are displayed in each department of the company at key locations of visibility
which enables employees to read and align themselves with the company’s quality needs. Key
quality concepts are also published on the back of each employee’s ID card. At the end of each
fiscal year, a management review is conducted to assess the company’s quality objectives for
suitability and effectiveness.
4.2.2 Quality Manual
The quality manual for MMI defines the overall quality procedures and documentation required to
achieve a standardized system. The quality manual shall include the following:
 Documentation for how to define requirements, develop designs, validate and verify
concepts and products, and
 How to address identify and address quality issues.
4.2.3 Control of Documents
Documents that are defined and required by the Quality Management System shall be controlled
by a Records Management system. All records shall follow an established procedure that will
create guidelines for the following:
 Approving documentation,
 Reviewing and updating documentation,
 Storing, distributing and retention lengths of all documentation,
 Ensuring status of documentation and revision levels are clearly marked,
 Ensuring process and product definition is up-to-date, and
 Identifying and controlling proprietary information.
The process for controlling documents “P-423 Control of Documents” is shown in Appendix A.
4.2.4 Control of Records
In addition to documentation control, a procedure for controlling records shall be established.
Similar to the documentation, the Records Management system will be used to ensure proper
storage, identification, and disposal of records. The process for controlling records “P-424 Control
of Records” is shown in Appendix A.
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Executive Management at Mean Machine INC takes a visible, hands-on approach to creating core
values, policies, strategies, expectations, requirements and customer focus. Management also
approves the implementation of the quality management system, which includes the quality policy,
objectives, and plan. It is the responsibility of the management team to ensure the quality
standards are reviewed on a regular basis. They will also ensure the quality policy is
communicated to all employees and approved suppliers. The quality objectives and policies are
mentioned in section 3 of this document. It is assured that sufficient resources are provided to
maintain and improve the quality of the company.

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5.2 Customer Focus
MMI views its product and service quality as being guided by its customers. MMI works closely
with clients to understand their requirements and expectations. Executive Management ensures
that not only are customer requirements understood, but they are acknowledged and met. The
specific needs of the customers are determined through surveys and market analysis. It is the
goal of MMI for every customer to receive quality products.
5.3 Quality Policy
It is the responsibility of management to develop and distribute a quality policy that includes the
following:
 Current and appropriate policies that meet the purpose of the organization,
 Guidelines for continuous improvement of the QMS,
 Quality objectives,
 Communications and training to ensure companywide understanding, and
 Timeframe for regular reviews of the policy.
5.4 Planning
5.4.1 Quality Objectives
Quality objectives are established to ensure the organization’s commitment to quality is
maintained. The objectives have been established and are listed below:
● Through standardized processes and periodic training of its employees, the organization
plans to maintain exemplary quality standards in product performance and delivery.
● By optimizing speed and performance MMI will ensure it exceeds both external and
internal customer expectation.
● MMI will ensure the product delivered complies with our company’s quality standard and
also meets the Los Angeles Federal Rules and Regulations.
● Through extensive research and quality procedures Mean Machine Inc. shall develop
products with unique design features. These design features will enhance product
capability to ride smoothly over bumpy terrain.
● Benchmarking initiatives will be used as a means of continuous research & development.
The goal of benchmarking is to focus on continuously improving our product and
processes.
● The management of Mean Machine Inc. will ensure there is alignment of the quality
policies and procedures with the business objectives. All quality and business objectives
will be communicated company-wide on a regular basis. This is to ensure MMI is
maintaining a culture of quality and continuous improvement.
The quality objectives are measured and reviewed against performance goals at each
management review meeting.
5.4.2 Quality Management System Planning
The quality system has been planned and implemented to meet our quality objectives and the
requirements of the ISO 9001 standard. It is communicated to all functions by the Quality

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Assurance Management and the Regulatory Affairs Management. Management shall ensure
that:
 The processes and documents laid out in this Quality Manual are followed by each
employee.
 The system shall also be robust. Changes in personnel should not affect the
implementation of the developed QMS.
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
Management is accountable for developing and outlining the Quality Mission, Quality Policy, and
regulatory agency requirements. They are also responsible for interpreting the quality data and
ensuring all standards are met. Anytime standards are not met, it is the responsibility of
management to review the issues and work with employees to correct quality issues. The
organizational chart of MMI (T-221) is available in the appendix. Mr. Vishaal Gopal is our Project
manager, which makes him the head of the company. He has appointed Mr. Rigved Karambelkar
and Ms. Han as the testing and Quality representative respectively.
Mean Machine INC has leased a facility in Gardena, California, where all design and production
operations take place. Mean Machine INC comprises of five highly skilled engineers equipped
with diverse skill sets. The team has been divided into specific functional areas, which are geared
towards meeting our business objectives. In addition to the five MMI members the company
employs Dr. Thomas Booth and Prithi Dominic Savio as members of an external consulting board.
They offer valuable support towards developing, maintaining, and improving our quality system.
The organization structure of Mean Machine INC is shown in the appendix.
Project Manager – Vishaal Gopal
The project manager leads the operation of the company towards achieving its goal. The project
manager regularly oversees monitoring and controlling the system, along with planning and
execution of materialistic and human aspects of the company. As the PM, it is also their
responsibility to engage the members of the team to remain motivated and committed, thereby
meeting and exceeding the goals of the company.
External Consulting Board – Dr. Thomas Booth & Prithi Dominic Savio
The external consulting board will bring their knowledge of quality systems, which will be utilized
in crucial development of the quality plan and policy. Dr. Booth is a veteran in teaching quality
concepts and pinewood derby designs. Prithi is a veteran in the field of quality and systems
control whose knowledge will be used to fine tune the customized manufacturing process.
Assembly & Testing – Rigved Karambelkar
The Assembly & Testing Engineer is responsible for the quality of both incoming sub-
assemblies/raw materials and the outgoing final product. Through regular testing, the department
ensures and verifies the production system is repeatedly outputting quality products that are
durable and meeting all specified requirements.
Procurement & Planning – Karthik Kulkarni
Procurement & Planning Engineer ensures availability of quality material at economical cost.
They also ensure all material is obtained at the appropriate time. The role of procurement and
planning is to minimize inventory and ensure quick turnaround from raw material to finished

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product. This is achieve through effective planning within the company and with external
suppliers.
Operations & Quality Engineer - Miaomiao Han
The Operations & Quality Engineer is responsible for ensuring adherence to the quality standards
set by the organization. They ensure the work force and production system produces minimal
rejections/errors during manufacturing. The Quality Engineer checks all the equipment for quality
periodically and also monitors the quality check points from raw material to final product shipment.
The Quality Engineer works in tandem with the Project Manager to maintain the standards of
quality within the company, and as a team, they are responsible for cascading the quality policy
of the company from the senior management level to the workshop level.
Marketing & Sales – Sarah Diehl
The Marketing & Sales Engineer will market Mean Machine as a company with a specific
emphasis on customer requirements and top class product quality. The marketing strategy
associated with the handmade vehicle comprises of two levels namely direct marketing and
indirect marketing. They will analyze historical sales data to forecast the demand for the vehicles.
Geographic sales data assessment will help pin point specific areas which exhibit high sales and
areas which require focused marketing campaigns.
5.5.2 Management Representative
The Project manager has appointed a Management Representative who has the following
responsibilities and authority:
● Ensure that the quality management systems are established, controlled, implemented
and functioning smoothly.
● Report management on the performance and results of the quality management system
and note and suggest room for improvement.
● Help understanding customer requirements to the management.
● Act as a representative with external parties such as customers or auditors on matters
relating to the implementation Quality.
5.5.3 Internal Communication
Management is responsible for establishing and implementing a communication plan. It is
imperative to the success of the company that all QMS standards and policies are communicated
to the entire company. Internal communications shall occur through management reviews, team
meetings, and emails.
5.6 Management Review
5.6.1 General
Management and the management representative review the QMS annually during management
review meetings. Records are organized and maintained for review during the meeting. Any
issues that seem to affect the quality system and diverge from the company’s quality policy would
be communicated during the meetings and recorded in a management review document, shown
on Form R-561. These reviews are held every quarter to ensure deficiencies in the quality systems
are addressed in a timely manner.

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5.6.2 Review Input
Assessment of the QMS is based on a review of information inputs that are sent to management
for review. These inputs include the following:
● Results of audits from internal and external auditors.
● Market analysis and customer feedbacks.
● Process performance reviews and product conformity.
● Updated actions required for correction and prevention.
● Follow-up actions required from the previous meetings.
● New implementations and changes that could affect the QMS.
● Recommendations for improvement.
5.6.3 Review Outputs
During review meetings, management will identify appropriate actions to be taken regarding the
following issues:
● New ways to improve the QMS and quality policies.
● Improvement of product in correlation with customer and quality requirements.
● Resource needed for implementation of the new actions devised from the review.
6 RESOURCE MANAGEMENT
6.1 Provisions of Resources
The Mean Machine Inc. company has applied a quality management System (QMS), which
incorporates ISO 9001-2008 standards. This system will implemented and maintained by all of
the managers and staffs. The system’s application is executed with full commitment and
dedication of the top level management, making sure that all the required resources are made
available in sufficient quantities and allocated accordingly across the departments. Our company
will employ lean thinking to ensure we continually improve the quality system. In order to enhance
customer satisfaction by meeting customer requirements, the ISO 9002-2008 will be executed in
each step of the product lifecycle. All of the company’s resources will be reviewed every year.
6.2 Human Resources
6.2.1 General
Every employee of Mean Machine Inc. can affect the quality of the final product, which contributes
to the satisfaction of the customer. Employees need training, and the company not only provides
training, but they also help everyone to develop a career and personal development plan.
Development of employees shall also aid in the quality of the company by increasing the
probability of manufacturing conforming products. The following table displays human resource
practices:

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Human Resource Practice
General recruitment and selection
General retention of staff
Job evaluation
Ability to attract top quality staff
Ability to retain top quality staff
Diversity/equal opportunity
General training and development
Managing flexible employment
Discipline
The design of job content
Reward systems
Academic leadership training and development
Processes of employee involvement
University leadership training and development
Appraisal
Two-way communication
Attendance/absence
Managing poor performance
Staff planning/succession planning
Performance management
6.2.2 Competence, Awareness and Training
To ensure each employee is performing to expectations, every position in the company has a list
job expectation. To gain more information and do a job more effectively, the staff should be
equipped with all necessary tools and skills. A computer-based system shall be used for access
to training and information. Stations shall be set up near the work areas for all Mean Machine
Inc. employees, and skills assessment software will be available for employees. The assessment
software will help ensure that employees are capable of achieving their assigned tasks. By using
the software, they can also diagnose their own work and improve individual ability. Finally,
employee skills can be examined by a 360-degree performance evaluation.
Below are some of the objectives of competence, awareness, and training:
● Learning plans and making schedule can help them identify losses in skills, gaps in
company, and meet the requirements. They can clearly identify how to improve their skills.
● Learning more about the management. The management program is not only the
manager’s responsibility but also the employee’s duty.

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● Planning and schedule are two important factors in industry. We will use Excel to analyze
the cost and balancing. Except for the Excel, we also use advanced software, such as
ERP system to help us reach goals.
● Continuous to innovate. Innovate is a big production in industry. The development of
“communities of practice” allows innovation to build a good approach to give information.
● Teamwork should be emphasized. Communicating and learning each other also help the
workers work happily. Only by this way, our company can make big success in the future.
● Software is a good tool to test the outcome, and it is quickly to know the standard value.
Besides, manual assessment control can also improve the efficiency of the test. After that,
we could make plan and production schedule to use the knowledge.
6.3 Infrastructure
To implement and improve the Quality Management System, the company needs a high quality
structure. The structure should include the basics such as:
● Buildings, workspace and utilities: Factory building, workshop, warehouse, office, rest and
fitness area.
● Process equipment: machines, tools, production line, energy system, and manual
process.
● Supporting service: Excel and ERP system.
6.4 Work Environment
In order to achieve the high standard of quality requirements, the top level managers, as well as
the support staff in Mean Machine Inc. should create a good work environment. A good work
environment includes the following:
● Philosophy: It builds their own philosophy to clarify what they want to be. The employees
should have their own goals and target.
● Learning and Control: Learning is a process of improvement. We hope that all of the staff
in our company should keeping learning and absorbing information from different aspects.
Our manager also should improvement their management. Communicating with other
managers is a good way learning. After that, they can train the workers. Control is also a
good way for company’s long-run development. By controlling the quality of the product,
we can finally reach the target of sales.
● Healthy: All of the staff in Mean Machine Inc. should have health insurance. Stable and
standardized processes can help them work hard and reduce waste. In other words, the
health insurance includes physical and mental insurance.
● Teamwork: We will pay more attention to the teamwork. And write it to the job description:
It is vital to communicate more and help each other.
7 PRODUCT REALIZATION
7.1 Planning of Product Realization
The plan for product realization shall incorporate input from organizations from each step of the
value stream, not just the Quality organization. This is to ensure diversity in view points and
minimize costly oversights. The plan shall include steps needed for product realization, which
include the following:

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● A list of the quality objectives and regulations,
● An established set of processes, documentation, and resources required to produce the
product,
● Clearly defined methods for ensuring product acceptance, and
● Records to be used as evidence that the product conforms to the requirements.
The quality objectives and regulations must align with the organization’s mission and vision as
described in Section 2. They must also be specific and measureable. Product acceptance shall
utilize inspections, verification and validation testing, and process monitoring. Each test and
process shall be defined by the appointed representatives from each organization. Completion
of the above noted steps will result in a clearly defined quality plan that should be followed during
requirement development, design, purchasing, production, and service.
7.2 Customer-Related Processes
7.2.1 Determination of Requirements
The requirements form the foundation of a project and should stem for the customer’s
expectations and demands. Development and documentation of the requirements shall be the
responsibility of the Design and Systems Engineering organization; however, it is expected that
Engineering incorporates input from organizations such as Marketing and Service Support and
utilizes the concept of concurrent engineering.
The Marketing and Sales team acts as a liaison between Mean Machine INC and its stakeholders.
It is the responsibility of Marketing to gauge market need through communications with potential
and existing customers and then communicate the customer’s requirements to the Engineering
organization. The Service Support group also acts as a liaison between Mean Machine INC and
stakeholders; however, their role is in support of the product after it’s been delivered. Service
Support shall help Engineering to define requirements by providing data from service issues and
successes. Based off of the input from the mentioned organizations, Engineering shall define
requirements that:
● Address the customer’s demands and expectations, which include delivery and in service
activities, and
● Follow all regulatory requirements associated with the product.
It is important to note that the defined requirements may include requirements not specifically
stated by the customer. These requirements must add value to the end product.
7.2.2 Review of Requirements
Once the list of requirements is developed, each requirement shall be assessed. The Engineering
organization will review each requirement to ensure that they are:
 Unambiguous, concise, and consistent with Mean Machine’s business objectives, and
 Verifiable, able to meet the design objectives.

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Any requirements not meeting these goals will be reviewed, revised, or removed as deemed
necessary. A record of the review must be maintained in the project’s archives and shall include
the results, including any additional actions needed. If a revision to the requirements is needed,
another review must take place prior to acceptance of the new requirements.
Sample documentation for the review is shown on Form R-722. Prior to committing to the
development of a product, an appointed customer shall confirm their acceptance of the form
through either a verbal or written statement. The appointed customer shall be selected based on
their interest and commitment to a new introductory product or product design improvement. A
document of the higher level requirements shall be provided to the customer by a MMI customer
representative.
7.2.3 Customer Communication
Communications with the customer shall be determined by the Marketing, Customer Service, and
Service Support organizations. It is the responsibility of these organizations to obtain information
and provide the proper channels related to the following:
● Product information,
● Contracts, ordering, and other enquiries, and
● Customer feedback.
7.3 Design and Development
7.3.1 Planning
During Design and Development Planning, Mean Machine INC shall develop the steps required
for completion of a robust design. Planning steps include the following:
● Determining design and development milestones,
● Creating the criteria necessary to ensure a milestone has been completed. This will
include verification and validation prior to entering a subsequent design/development
phase, and
● The authorities for the design and development.
In order for design and development to be successful, an emphasis is needed on cross functional
communications. A lack of communication between organizations leads to poor quality and a
breakdown in the implementation of the designs.
7.3.2 Inputs
In order for the design and development to progress, there are several inputs necessary. These
inputs include:
● Functional and performance requirements,
● Packaging requirements,
● Regulatory requirements, and
● Information and lessons learned from previous designs.
The inputs shall be recorded on Form R-732.

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7.3.3 Outputs
The purpose of the Design and Development outputs is to reconcile the listed inputs. For Mean
Machine INC, the final output is a vehicle that can be used for pinewood derby style competitions.
To complete this stage, all analysis and requirements are used to develop Engineering drawings.
The drawings that are developed shall:
 Meet the input requirements,
 Provide enough information for purchasing and manufacturing to develop a plan for how
to receive and assemble supplied parts,
 Provide a method of determining product acceptance, and
 Provide instructions for proper product use.
7.3.4 Review
After the designs are created and during subsequent design revision activities, a thorough review
must be conducted to ensure the proposed Design and Development plan meets all requirements.
The purpose of the review is to also highlight any issues with the design prior to reaching
production. The review must include organizations such as Engineering, Manufacturing, and
Purchasing. Each organization is needed to ensure the design has components that can be
purchased or manufactured. The review will also verify organizations can inspect components to
the necessary accuracy and precision to ensure product conformance. Any problems discovered
during the review phase shall be investigated and addressed. Documentation of the review shall
be shown on Form R-734, and the results of the review shall be maintained in the project’s
archives.
7.3.5 Verification
Verification is a major portion of the design and development of the product. Verification testing
is required to ensure the product meets the previously defined specifications and requirements.
Documentation of the results of verification and all necessary actions, including designs needing
additional review, will be recorded on a form similar to Form R-735.
7.3.6 Validation
Validation is another crucial process during the development of the product. Validation testing
will ensure the product meets the customer requirements and performs all expected functions to
the customers’ satisfaction. Documentation of the results of validation and all necessary actions
will be recorded on a form similar to Form R-736.
7.3.7 Control of Design and Development Changes
Design and development changes shall be clearly documented to ensure configuration control.
Any revisions to the design that affect the fit, form, or function shall require new part numbers and
design releases that must be reviewed, verified, and validated. Prior to releasing the new design,
the revisions must be evaluated by all affected organizations to ensure additional revisions for the
other commodities. Design changes will be documented on Form M-737. The review, verification,
and validation activities shall be documented on Forms R-734, R-735, & R-736.

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7.4 Purchasing
7.4.1 Purchasing Process
The purchasing process includes steps for selecting qualified suppliers, along with ensuring the
components provided by suppliers meet design requirements. A thorough list of supplier
requirements shall be created to ensure all stakeholders understand their expectations and
responsibilities. Prior to selecting a supplier, the Purchasing team shall develop a procedure for
the selection and approval of vendors. The expectation of the suppliers is to assure efficient,
reliable, and conforming materials to be used during the assembly of the final product. A process
for auditing the external suppliers shall also be created by the Purchasing organization.
Documentation of the supplier evaluation shall be maintained using Form R-741.
7.4.2 Purchasing Information
Purchasing information shall be created by the Purchasing team and will include the product
description and quantity of components needed. The purchasing information shall also include a
well-defined list of expectations for the supplier and their products. These expectations shall
include:
 Critical design features, along with processes used to inspect and verify conforming parts,
 Requirements that shall ensure personnel are qualified and trained to manufacture
products that meet the requirements specified by MMI, and
 Quality management system requirements.
7.4.3 Verification of Purchased Product
To ensure products received from the approved vendors conform to the design requirements,
MMI shall develop an incoming product inspection process. The inspections shall be performed
prior to accepting the component and will verify the type, quantity, and design and purchasing
requirements have been met. Documentation of the incoming inspections shall be maintained on
Form R-743. Suppliers consistently not meeting MMI requirements shall be accessed and notified
by MMI that remedial actions are required.
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
Control of production plays a key role in reducing variability in our products. A controlled, stable
environment leads to better assessments of common and special case variation, which then lead
to faster corrective action response time and better identification of process improvements. The
controlled conditions shall include:
● A system for maintaining and allowing company wide use of product definition;
● A defined set of work instructions, which includes production sequencing of when the
instructions need to be completed;
● A set of necessary tools and equipment;
● A method for calibrating or verifying tools and equipment are functioning properly;
● A method for monitoring and measuring the health of the production system;
● A defined process for product releases, delivery, and service activities.

18
If at any point the controlled conditions are not met, a process shall be in place to notify the
responsible organization.
7.5.2 Validation of Processes
Validation of processes is necessary to ensure the production process runs, especially for
operations that cannot be verified or measured upon completion. A process or test shall be
developed by Engineering and Manufacturing to ensure the output of the operation is consistent
and meets all requirements. This shall be accomplished by having defined criteria, which shall
include required equipment, personnel qualifications, and procedures. Form R-752 provides the
checklist of requirements needed to approve a special process.
7.5.3 Identification and Traceability
Mean Machine INC. shall utilize a configuration management system to ensure all processes,
products, and operations can be traced back to a defined function and requirement. Any process,
product, or operation that cannot be traced back to a specific customer or design requirement
shall be reassessed to determine its value in the product design, development, and manufacturing
system.
Identification of designs and physical parts shall also be required to ensure traceability in the
event a defect occurs, corrective action is required, or a process improvement is implemented
that requires new components, equipment, or tools. Identification of personnel completing
production processes shall also be maintained to help identify training and improvement
opportunities. Form R-753 shall be used to maintain identification and traceability records.
7.5.4 Customer Property
The industry and market Mean Machine INC. operates within does not require the need to handle
or incorporate customer property into the design or production system. However, should the need
arise to control customer property, MMI shall ensure all property is protected and handled with
care. Any lost or damaged customer property that is within MMI’s system, shall be MMI’s
responsibility to replace or compensate the customer.
7.5.5 Preservation of Product
MMI shall be responsible for maintaining the quality of the products during production and
delivery, which includes storage, handling, and packaging. Engineering and Manufacturing shall
be responsible for developing a plan to ensure all products preserved and maintained at a
specified quality standard.
7.6 Control of Monitoring and Measuring Equipment
The Engineering and Manufacturing team shall determine a process for monitoring and measuring
conformity of the product components, final product, equipment and tools. This will include how
inspections will be implemented; how equipment and tools will be calibrated and certified; a
timeline for when equipment and tools need to be re-calibrated and re-certified; and how to
document and monitor all inspection and calibration activities. Records of the calibration and
inspections shall be maintained on Form R-760.

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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 General
Mean Machine Inc.’s goal and vision is to manage, analyze, improve and abide by the quality
management system while ensuring that the delivered product meets the customer’s
requirements and conforms to the various prescribed standards. We strive to achieve durability,
affordability and precision in the products that we deliver.
To measure and improve business performance and monitor customer satisfaction and defect
rates, we can make use of balance scorecards. The primary factors to be taken into consideration
while performing these measurements are specificity, timeliness and relevance. These
techniques can be used to ensure that effective quality management has been achieved.
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
Our products shall be designed and assembled to cater to the new demand for 3-wheel cars for
the Pinewood Derby. Considering that it’s a new product and has a lot of potential, we take our
customers’ needs to be the absolute priority. Consequently, customer satisfaction and customer
feedback is the key aspect of the quality monitoring and management system. The results of
these customer feedbacks are shared with the design and assembly team to motivate them to
develop better parts or modify the process, if necessary. We use a scorecard while assessing the
customer feedback. The customers rate their satisfaction on a scale of 1-10 based on the
product’s performance in terms of assembly quality, durability, consistency during runs and
packaging quality. An average score is then generated and the company uses this score to
determine the overall satisfaction of the customer per Table 1A in the Appendix.
Some other methods to determine customer satisfaction are surveys, intent to repurchase, loyalty
to the brand and general overall communication.
8.2.2 Internal Audit
Mean Machine Inc. conducts internal audits every 6 months to ensure that the organization’s
various branches are performing at full potential and no shortcomings can be seen in the
organizational process. The audit consists of the following:
• Product and process conformance tests.
• Conformance to IS0 9001 standards.
• Resource allocation, resource usage and lean management.
• Perusal of planned activities and necessary actions.
• Analysis, detection and control of defects and variations.
The outcome of this audit is recorded and tracked over the course of company operations to
monitor progress and track systemic defects, if any. Form R-822 is an internal audit record form
that includes audit observations and recommended course of action. This report is reviewed by
top management and changes are made to the process or mode of operations depending on what
is necessary. Form R-822 also establishes responsibilities and requirements of auditing and audit
reporting, thus making it an important tool of quality management.
8.2.3 Monitoring and Measurement of Processes
Quality tools such as PFMEA are used to monitor and measure various processes. This helps the
design and assembly teams to focus on recurring errors and rectify them, thus improving the

20
process. Moreover, tools such as histograms, checklists, flowcharts, scatter and control charts
are created to assess effectiveness of the process. In case a variation is found in the process,
the root cause of that variation is located. A team meeting helps to create a corrective action plan
to remove the root cause of the variation or defect. Finally, the dashboard method helps transform
process data into easily accessible information for the top management.
8.2.4 Monitoring and Measurement of Product
Mean Machine Inc. carefully analyzes the individual components of the car to verify that each
single component adheres to the structural, dimensional and constructional requirements. It goes
through a host of inspection and test run stages before delivery. A finished product is only
released to the customer after a full conformance check is run on the product. If any defect or lack
of adherence to conformance criteria is found, the product is not released. This data can be
recorded using Form R-824, a product conformance record. It includes product requirements,
related tolerances and pass/fail data.
It is imperative that the inspection and testing be conducted by trained personnel so as to
eliminate any ambiguity in the inspection report. If a variation is found in any single product, it
must be recorded, assessed and analyzed so as to identify if the same variation is found in
another product. Corrective and preventive action must be initiated by top management to ensure
that the defect rate is minimized.
8.3 Control of Nonconforming Product
Products that do not pass safety checks, inspections and product conformance tests should be
taken off the delivery system and must be dealt with depending upon the seriousness of the
defect. The defective products must then be subject to scrapping, reconstruction or reassembly
depending on the kind of defect that’s been detected. The root cause of the defect must be located
and checked for repetition in other products from the same assembly line. This ensures that a
systemic problem is not propagated into the delivery line. A procedure labeled P-830 is initiated
to deal with nonconforming products. Form R-830 records nonconforming products and
suggested corrective action.
8.4 Analysis of Data
Analysis, presentation and interpretation of data is one of the key aspects of quality and process
improvement. Data is collected using tools such as affinity diagrams, control charts and check
sheets. Nonconforming products or inefficiencies must be identified and their root causes must
be located. Various aspects of product performance such as customer requirements,
conformance to requirements, supplier information and customer feedback must be taken into
consideration. Variations and deviations from ideal states can be determined by conducting
statistical analyses. Tools such as GRR are useful in precision and accuracy tests.

21
8.5 Improvement
8.5.1 Continual Improvement
Mean Machine Inc. believes in the idea of continuous improvement. This is facilitated and
motivated by various factors. Some of the practices and techniques are listed below:
● Waste reduction and management
● Internal audits
● Implementation of stretch goals
● Customer feedback analysis
● Cycle time reduction
● Adherence to quality policies
● DMAIC
8.5.2 Corrective Action
Once a defect, variation, a series of variations or, at worst, a systemic defect is detected, the
primary objective is to rectify that error and make sure it does not repeat. Corrective action is of
prime importance in the quality management system. Some of the measures implemented by
Mean Machine Inc. are as follows:
● Data and product record analysis
● Root cause identification by process and product testing
● Analyzing multiple possible solutions and determining the best
● Reviewing customer responses and taking corrective action
● Quantification of the impact of the corrective action over a course of time
● Application of agile project management principle
Form R-852 is the corrective action records form that provides adequate information about root
causes and their corrective measures.
8.5.3 Preventive Action
At Mean Machine Inc., we believe that preventive action is more cost effective and profitable in
the long run, as compared to corrective action. Mistake proofing and simplicity of design is an
approach towards preventive action. Moreover, the concept of poka-yoke also helps us input
countermeasures within the product itself, to avoid nonconformities. The impact of preventive
action is also monitored and quantified for future reference.

22
9 APPENDIX A: DOCUMENTS
T-221 Organizational Structure

24
P-423 Control of Documents
1. Process: This procedure is a description of how MMI handles and controls its documents.
It defines how the documents are controlled and reviewed by the team members.
2. Application: All the employees of MMI should abide by the rules and policies of the
organization.
3. Scope: This procedure is used for all the documents at MMI following the ISO standard.
4. Responsibilities: Team Manager approves all the documents and ensures that the
procedures are followed by the employees. The quality manager is responsible of
reviewing the documents and storing them along with all relevant documents.
5. Procedure: A standardized format of documents is used. Every document has its own
unique identity so it is easier to sort it out. All documents should be clear in its language.
Every document should be approved by the quality manager before it is shown to higher
management. Any changes in the document will be noted to the quality manager and will
be implemented only on his approval. If a document has to be replaced it should be
sanctioned by the department as well as the quality manager.
P-424 Control of Records
1. Process: This procedure is a description of how MMI handles and controls its records. It
defines how the records are controlled, maintained and reviewed by the team members.
2. Application: All the employees of MMI should abide by the rules and policies of the
organization.
3. Scope: This procedure is used for all the records at MMI following the ISO standard.
4. Responsibilities: Team Manager approves all the records and ensures that the
procedures are followed by the employees. The quality manager is responsible of
reviewing the records and storing them along with all relevant records.
5. Procedure: Records should be easy to access and should be kept in hard and soft copies.
The records should be named and stored properly. The managers should be able to order
the records when in time of need. All the records are final and cannot be changed. Only
the employees of the company will have access to the records, No special cases will be
allowed. Approval of the quality manager is required for the viewing of records.

25
Form R-561 Mean Machine INC Management Review Meeting
Date: Start time: End time:
Attendees:
Topics Action Details Department
Responsible
Date Last time
Management Meeting
Objective
Current Organizational
Structure
Quality Policy Statement
Quality Objectives
Resource Management
R & D Initiatives
Customer Feedback
Product, Process and
System Conformance
QMS Continuous
Improvement Strategy
Non-Conformance
Corrective Actions
Preventive Actions
Follow up Actions
Recommendations for
Improvement
Planning for Training
Prepared by(
Management
Representative Signature)
Approved by ( Team
Leader Signature)

26
Form R-722: Review of Requirements
ID Review Question
Complete
(Y/N)
Comment
1
Have appropriate requirement standards been
followed?
2 Are all terms and units defined?
3
Are all requirements written clearly and with an
appropriate level of detail?
4
Do the requirements provide a basis for the
design?
5
Are the requirements free of duplication and
conflict with other requirements?
6 Is each requirement verifiable and measureable?
7 Is each requirement unique and traceable?
8
Does each requirement add value and address a
specific function?
9
Has user documentation and training
requirements been addressed?
1
0
Other
Authorized Signatures Date
1
2
3
4

27
Form R-732: Product Inputs
Design Requirement
Type
Descriptio
n
Comment
s
Functional/Performance
1
2
3
4
5
Packaging
1
2
3
4
5
Regulatory
1
2
3
4
5
Safety
1
2
3
4
5
Other
1
2
3
4
5
Authorized Signature
Date

28
Form R-734: Design Review
Component
Requirement
Traceability Measurement
Targe
t
Benchmar
k
Othe
r
Design Signature Date
Manufacturing Signature Date
Purchasing Signature Date

29
Form R-735: Verification Review
I
D
Requirement Review Component
Complete
(Y/N)
Comments
1 Is the function/component traceable to
a defined requirement?
2
Is there a function and performance
criteria that must be met for the system
to be acceptable?
3
Does the specification include all
system needs? Ex: tooling, equipment,
training
4 Have all dependent systems been
identified?
5 Are all design and system constraints
defined?
6 Have all regulatory requirements been
addressed?
7
Have all quality characteristics been
addressed? Ex: usability, availability,
efficiency, flexibility, maintainability
8 Do the specifications agree with all
relevant documentation?
9
Does each function/component have
only one interpretation? If multiple
interpretations can be derived, are all
clearly defined?

30
Form R-736: Validation Review
ID Documentation
Complete
(Y/N)
Comments
1 Validation Plan
2 Requirements Test Specification
3 Functional Test Specification
4 Product Test Specification
5 Manufacturing Plan

31
Form R-737: Design Change Request
Change Request No.
Responsibility
Status
Investigation Summary
Description of Design Change
Authorized Signature
Design Engineer Date
Stress Engineer Date
Manufacturing Rep Date

32
Form R-741: Supplier Evaluation
Supplier Name:
Supplier Representative:
Criteria
Complete
(Y/N)
Comment
s
Is there an up-to-date Quality Manual?
Is there a configuration management process in place?
Are they ISO 9001 certified?
Is there a plan for training employees and is it implemented?
Are revisions to drawings and processes reviewed and approved?
Are all materials properly handled and identified?
MMI Representative Signature:
Date:

33
Form R-743: Incoming Product Inspection
Inspector Signature:
Date:
Part Identification:
Quantity Inspected:
Inspection Criteria
Pass/Fai
l
Are all design specifications met?
Are all parts properly identified?
Is all purchasing information correct?

34
Form R-752: Process Validation Review
Criteria
Complet
e (Y/N)
Comment
s
Has an acceptance criteria been developed?
Have employee training and certifications been
established?
Have validation procedures been reviewed?
Has all equipment required for validation been
identified?
Have all validation records been created,
identified, and controlled?
Design Signature: Date
Manufacturing Signature: Date
Quality Signature: Date

35
Form R-753: Identification and Traceability
Identification
Product
Detail Traceable Requirement
Part No.
Manufacturing Lot No.
Purchasing Order No.
Customer Order No.
Tracking No.

36
From R-760: Calibration & Inspection
Inspector Signature:
Date:
Tool/Equipment Identification:
Quantity Inspected:
Date of Next Inspection:
Inspection Criteria Pass/Fail
Does the tool/equipment meet calibration
requirements?
Has the tool/equipment been damaged?
Does the tool/equipment meet all design and
performance requirements?

37
FORM R-822 Internal Audit Record and Results
Auditee Name: Record Number:
Process Name:
Department:
Date: Time:
Audit Findings:
Recommended Actions:
Completed By:
Auditor Name:
Signature: Date:
Audit Director:
Comments:
Signature: Date:
Refer to Form P-822 for use of this form

38
FORM R-824 Product Conformance Record
Batch Number: Record Number:
Product Name:
Date: Time:
Product Information
# Requirement Tolerance Pass/Fail
1
2
3
4
5
6
7
Completed By:
Quality Assurance Representative:
Signature: Date:
Approved By:
Quality Assurance Representative:
Comments:
Signature: Date:

39
FORM R-830: Control of Nonconforming Product Record
Product Name: Product Conformance Record Number:
Date: Time:
Nonconforming Product Information
Completed By:
Nonconformance Responsible Party:
Signature: Date:
Approved By:
Manager:
Comments:
Signature: Date:

40
FORM R-852: Corrective Actions Records and Results
Product Name:
Control of Nonconforming Product Record Number:
Date: Time:
Root Cause Analysis Information:
Completed By:
Corrective Action Responsible Party:
Signature: Date:
Approved By:
Management Review Board Member:
Position:
Comments:
Signature: Date:
Table 1A

41
Score Customer Satisfaction
90-100 Totally satisfied
75-90 Generally satisfied
50-75 Generally dissatisfied
0-50 Totally dissatisfied

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