ki quality manual rev. d 12-28-2012

7/29/2019 KI Quality Manual Rev. D 12-28-2012

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ISO 9001:2008

Quality Management System (QMS)Manual

Revision: Page:

12/26/2012 1 of 35Reviewed by Quality Manager

Signature/Date:Lin Lin Aung (Dec. 26, 2012)Approved by:

Signature/Date: Chansouk Inthabandith (Dec. 28, 2012)

All printed copies of this manual are for reference only. The official, controlled copy is the

change-controlled electronic file in the K-I Machine intranet.


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Document: Revision: Page:

Quality Manual 2-6-2012 2 of 35

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i Revisions:

Rev. Section Description of Change Initiator Date

- Entire Manual Initial Release PThammavong 07/17/2006

A Entire Manual Combined individual sections into onemanual

JOller 12/24/2009

B 6.0 Updated Organization Chart JOller 4-13-2010B2 FC 6.2 Updated Organization Chart A Inthabandith 02-11-2011C FC 6.2,

Appendix A,throughout

the manual.

Updated Organizational Chart,

procedures that were notimplemented, various wording.

S. LeWellen 02-06-2012

D FC 6.2,Appendix A,

PFC 4.1, 7.3,throughout

manual

Updated Org. Chart, removed oneexclusion, revised Design and

Development section 7.3, wordingchanges throughout.

L. Aung 12-26-12


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0. Table of Contents

SECTION TITLE Page

Title Page Title Page and Approvals 1

i Revisions 2

0 Table of Contents 3

1.0 Scope 6

2.0 Normative References(Reference Documents) 6

3.0 Terms and Definitions 6

4.0 Quality Management System 7

4.1 General Requirements 7

PFC 4.1 Process Map 8

4.2 Documentation Requirements 9

4.2.1 General 9

4.2.2 Quality Manual 9

4.2.3 Control of Documents 9

4.2.4 Control of Records 10

5.0 Management Responsibili ty 10

5.1 Management Commi tment 10

5.2 Customer Focus 11

5.3 Quality Policy 11

5.4 Planning 12

5.5 Responsibility, Authorit y and Communication 12

5.6 Management Review 14

6.0 Resource Management 15

6.1 Provision of Resources 15

6.2 Human Resources 15

6.3 Infrastructure 16

6.4 Work Environment 16

FC 6.2 Organization Chart 17


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SECTION TITLE Page

7.0 Product realization 18

7.1 Planning of Product Realization 18

7.2 Customer-related processes 19

7.2.1 Determination of Requirements Related to t he Product 19

7.2.2 Review of Requirements Related to the Product 19

7.2.3 Customer Communications 20

7.3 Design and Development 21

7.4 Purchasing 22

7.4.1 Purchasing Process 22

7.4.2 Purchasing Information 23

7.4.3 Verification of Purchased Product 23

7.5 Production and services provision 23

7.5.1 Control of Production and Service Provision 23

7.5.2 Validation of Production and Service Provision 25

7.5.3 Identification and Traceabilit y 26

7.5.4 Customer Property 26

7.5.5 Preservation of Product 27

7.6 Control of Monitoring and Measuring Equipment 27

8.0 Measurement, Analysis and Improvement 28

8.1 General 28

8.2 Monitor ing and measurement 29

8.2.1 Customer Satisfaction 29

8.2.2 Internal Audit 29

8.2.3 Monitor ing and Measurement of Processes 30

8.2.4 Monitor ing and Measurement of Product 31

8.3 Control of Nonconforming Product 32

8.4 Analysis of Data 32

8.5 Improvement 33


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8.5.1 Continual Improvement 32

8.5.2 Corrective Action 33

8.5.3 Preventive Action 33

Appendix A List of Key Internal QMS Documents Referenced in this Manual 34

Appendix B Terms and Definitions 35


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1.0 Scope

1.1 General

K-I Machine Tool & Production, Inc. Quality Management System (QMS) conforms to ISO

9001:2008 as described within the American National Standard, Quality Management System

Requirements.

1.2 Application

Our QMS complies with all applicable requirements contained in ISO 9001:2008 with the

following exclusions;

Although addressed in this QMS, K-I Machine Tool & Production, Inc. has no DesignDevelopment responsibilities as defined by this standard.

These functional exclusions do not affect K-I Machine Tool & Production, Inc. ability or

responsibility, to provide services that meet customer and applicable regulatory requirements.

2.0 Reference Documents (Normative References)

The following external documents contain provisions which, through reference in this manual,

constitute provisions of our QMS:

ISO 9001:2008, Quality management systems Requirements

ISO 9001:2005 Quality Management Systems Fundamentals & Vocabulary ISO/TS 16949:2009, Quality management systems particular requirements for the

application ofISO 9001:2008for production

APQP, Advanced Product Quality Planning

FMEA, Potential Failure Mode and Effects Analysis

PPAP, Production Part Approval Process

SPC-3, Statistical Process Control (SPC)

MSA-3, Measurement Systems Analysis (MSA)

Appendix A contains a List of Key QMS procedures referenced in this manual and defines the

key top level processes for implementing our quality policy.

3.0 Terms and Definitions

Acronyms, terms, vocabulary and definitions unique to our organization, customers, industry andregion and referenced throughout our QMS are contained inAppendix B, Terms and Definitions.


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4.0 Quality Management System

4.1 General Requirements

K-I Machine Tool & Production, Inc. has documented; implemented and maintains a Quality

Management System and continually improves its effectiveness in accordance with the ISO

9001:2008 International Standard.

K-I Machine Tool & Production, Inc. has:

a) Identified the processes needed for the QMS and their application throughout theorganization (see 1.2).

b) Determined the sequence and interaction of those processes.c) Determined the criteria and methods needed to ensure that both the operation and control

of these processes are effective.

d) Ensured the availability of resources and information necessary to support the operationand monitoring of these processes.

e) Monitors, measures and analyzes these processes.f) Implemented actions necessary to achieve planned results and continual improvement of

these processes.

K-I Machine Tool & Production, Inc. manages these processes in accordance with the

requirements of ISO 9001:2008.

Where K-I Machine Tool & Production, Inc. chooses to outsource any services that effect

product conformity to requirements, K-I Machine Tool & Production, Inc. ensures control over

such processes. Control of such outsourced processes is identified within the QMS.


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ProductRealizationProcesses

PRP

QMPe

Da

Product/Process

Data

Policies &

Directions

Policies &

Directions

Customer

Re

Ne

PROCESS MAP

PRP 08

PRP 02

Sales &Order

Processing

PRP 01

Inspection,Test &

Metrology

PRP 07

Receiving

PRP 03

Delivery

PRP 05 & 6

ContinualImprovement

MRP 03

Resources

Resource Mgmt Processes (RMP)

PersonnelCompetence

and Skills

RMP 01

Information,Doc Control &

Info Tech

RMP 02

Facilities,Equipment &

Work Envirmnt

RMP 03

Measurement, A nalysisand Improvement Processes (MIP)

CustomerComplaints/Satisfaction

MIP 04

Control ofNon Conforming

Product

Internal Audit &Analysis of Data

MIP 02

Corrective &Preventive Action

MIP 03

MIP 01

Purchasing

Productionand QualityPlanning

Mngmn

tResponsibility

Proc

esses(MRP)

ManaRe

MR

MR

PlanObj

RFQs, Feasibility, Quotes,Customer Orders

Customer

PRP 08a

Outsourced

Processes N/A

PFC 4.1 (ProceMap)


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4.2 Documentation Requirements

4.2.1 General

The QMS documentation includes:

a) A documented statement of our Quality Policy and Quality Objectives.b) K-I Machine Tool & Production, Inc., Quality Management Systems Manual.

c) Documented procedures as required by ISO 9001:2008.

d) Documents needed by K-I Machine Tool & Production, Inc. to ensure the effective

planning, operation and control of its processes.e) Records required by ISO 9001:2008 (Section 4.2.4).

4.2.2 Quality Manual

This manual is part of our QMS that defines the scope of our QMS and documents the policy,procedures and processes needed to implement our quality policy and achieve our qualityobjectives. This manual also documents justifications for exclusions fromISO 9001:2008

requirements (Section 1.2) and defines the overall sequence of and interaction between our key

QMS processes (PFC 4.1, Process Map).

4.2.3 Control of Documents

The Quality Manager has overall responsibility for ensuring that all QMS documents, includingforms used to create quality records are controlled per procedures detailed in OP 4.2.3andsummarized below:

a) Approve documents for adequacy prior to issue.b) Review, update as necessary and re-approve documents.c) Ensure that changes and the current revision status of documents are identified.d) Ensure that relevant versions of applicable documents are available at points of use.e) Ensure that documents remain legible, readily identifiable and retrievable.f) Ensure that documents of external origin (including customer engineering

standards/specifications) are identified and their distribution controlled.g) Prevent the unintended use of obsolete documents, and to apply suitable identification to

them if they are retained for any purpose.

4.2.3.1 Engineering specifications.

The Quality Manager oversees our process for assuring the timely review, distribution and

implementation of all customer engineering standards/specifications and changes based oncustomer-required schedule. Reviews are considered timely if performed within two working

weeks of receipt. A change requires an updated record of customer production part approval if

the change affects Production Part Approval Process (PPAP) documents.


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4.2.3.2 Master Lists.

Requirements for the establishment and maintenance of Master Lists of internal and externalQMS documents are defined in OP 4.2.3.

4.2.4 Control of Records

The Quality Manager has overall responsibility for ensuring that all records required for the

QMS (including customer-specified records) are controlled and maintained to provide evidence

of conformance to requirements and effective operation of the QMS. Records will remainlegible, readily identifiable and retrievable. Procedure OP 4.2.4 has been established to define

the controls needed for the identification, storage, protection, retrieval, retention and disposition

of records. Records are retained for a period defined by the customer, applicable regulatoryrequirements and/or K-I Machine management, as applicable, and then disposed of in accordance

with applicable requirements. Records may be in the form of hard copy or electronic media.

5.0 Management Responsibility

5.1 Management Commitment

Top Management provides evidence of its commitment to the development, implementation andimprovement of our QMS in very tangible ways.

Our quality policy statement (Section 5.3) documents and communicates the importance of

meeting or exceeding all applicable requirements (including customer, regulatory and legal

requirements) through continual improvement of our processes, products, and services.

We ensure that our quality policy is understood, implemented, and maintained at all levels of theorganization and through periodic management review of the quality policy statement and

quality objectives (Section 5.4). In addition, our quality policy and objectives are communicated

and deployed throughout the organization through individual performance objectives establishedand reviewed during employee performance reviews (Section 6.2.2).

All managers demonstrate their commitment to the development and improvement of the QMS

through the provision of necessary resources (Section 6.1), through their involvement in theinternal audit process (Section 8.2.2), and through their proactive involvement in our continual

improvement activities (Section 8.5.1) where emphasis is placed on improving both effectivenessand efficiency of our key QMS processes.

Top management reviews product realization and support processes to assure both effectiveness

and efficiency during management reviews (Section 5.6.2).


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5.2 Customer Focus

Our quality policy statement articulates our commitment to our customers (Section 5.3).

Top management ensures a proper customer focus is established and maintained through the

following activities:

a) Customer complaints and other customer input/feedback are continually monitored andmeasured to identify opportunities for improvement (Section 8.2.1).

b) We continually look for other ways to interact directly with individual customers toensure a proper focus to their unique needs/expectations is established and maintained:

e.g. customer audits, customer visits, trade shows, joint planning sessions, etc.

c) These customer focused communications and interactions yield clear, explicit customerrequirements and expectations in the form of a contractual agreement or customer order.

The Vice President has overall responsibility for ensuring that specified and unspecifiedrequirements are determined, understood, and converted into requirements (Section 7.2).

5.3 Quality Policy

K-I Machine Tool & Production, Inc. is a manufacturer with general machining andfabrication capabilities, dedicated to Continual Improvement of the Quality Management

System and meeting or exceeding customer needs and expectations.

Our quality policy statement indicates our commitment and focuses on what is important to us as

an organization: achieving customer satisfaction; and it prescribes the method by which we

accomplish this: by continually improving processes, products, and services to ensure theyconsistently meet or exceed requirements. Moreover, our quality policy statement acts as a

compass in providing the direction and a framework for establishing key corporate level

performance measures and related improvement objectives (Section 5.4.1).

We ensure that our quality policy is communicated and understood at all levels of the

organization through documented training, regular communication, and reinforcement duringannual employee performance reviews (Section 6.2.2).

Our quality policy statement is controlled by inclusion in this manual, and along with all policiescontained in this manual, is reviewed for continuing suitability during management review

meetings (Section 5.6).


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5.4 Planning

5.4.1 Quality Objectives

Our overall quality goal is to achieve our quality policy. Further, we establish both corporate

level and operational level improvement objectives that are measurable and achievable within a

defined time period. Corporate level improvement objectives, derived from our customer

goals/targets, are reviewed for achievement during management reviews (Section 5.6.2). Allmanagers of key QMS processes, monitor and measure performance of processes within their

area(s) of responsibility and, where appropriate, establish measurable operational level

improvement objectives consistent with our quality policy and corporate level improvementobjectives.

Top management utilizes the management review process (Section 5.6.2) to define qualityobjectives and measurements to be used to deploy our quality policy. Specific measurable

objectives adopted will be based on achievable performance within a specified time frame,

driven by the following objectives:

a) Achieve 85% On-Time delivery to our Customers (Section 7.5.1.6)

b) Eliminate Customer returns and complaints regarding quality issues (Section 8.2.1).

5.4.2 Quality Management System Planning

The QMS planning process involves the establishment and communication of our quality policy

(Section 5.3) and objectives (Section 5.4.1) through issuance of this manual and its associated

procedures, and through the provision of resources needed for its effective implementation(Section 6.1). Accordingly, this manual constitutes our overall plan for establishing,

maintaining and improving an effective QMS. Our management review process (Section 5.6)

and internal audit process (Section 8.2.2) ensure the integrity of our QMS is maintained whensignificant changes are planned and implemented that affect our key QMS processes.

The Quality Manager develops appropriate quality planning documents for specific products,

projects or contracts whenever customer requirements exceed the capability or intent of theproduct realization and support processes described in our QMS (Section 7.1).

5.5 Responsibilities, Authority and Communication

5.5.1 Responsibility and Authority

The President sets direction and ensures the success of our business through the clear definitionand communication of QMS responsibilities and authorities. Other members of Top

Management include: the V.P. and the Quality Manager. The interrelationship of Top

Management and other key personnel, who manage, perform and verify work affecting quality is


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documented on our Organization Chart (FC 6.2) and via the Operational Procedures and workinstructions.

Overall QMS responsibility and authority is as follows:

Top Management Members of Top Management are ultimately responsible for thequality of K-I Machines products and services since they control the systems and

processes by which work is accomplished. Top Management is responsible for BusinessPlanning, development and communication of our quality policy (Section 5.3), QMS

Planning (Section 5.4.2) including the establishment and deployment of objectives

(Section 5.4.1), the provision of resources needed to implement and improve the QMS(Section 6.1) and management reviews (Section 5.6).

Management All managers are responsible for execution of the Business Plan andimplementation of the policy, processes and systems described in this manual. All

managers are responsible for planning and controlling QMS processes within their area(s)of responsibility, including the establishment and deployment of operational level

objectives (Section 5.4.1), and the provision of resources needed to implement andimprove these processes (Section 6.1). Managers also conduct employee performance

reviews (Section 6.2.2). Management with responsibility and authority for corrective

action are notified promptly of non-conformities (Section 8.5.2). Management ensures

that production across all shifts is staffed with personnel in charge of, or delegatedresponsibility for product quality (Section 7.5.1.1).

Employees - All employees are responsible for the quality of their work andimplementation of the policy and procedures applicable to processes they perform

(Section 8.2.3). Personnel responsible for product quality have the authority to stopproduction to correct quality problems (Section 8.3). Employees are motivated and

empowered (Section 6.4) to identify and report any known or potential problems andrecommend related solutions through internal audits (Section 8.2.2) and/or the continual

improvement and corrective/preventive action processes (Section 8.5).

Detailed responsibilities and authorities for QMS implementation and improvement are

contained in lower level documents referenced throughout this manual and other QMS

documents including procedures, flow charts, job descriptions, work instructions, etc.

5.5.2 Management Representative

The Quality Manager of K-I Machine Tool & Production, Inc. is the ManagementRepresentative. The Management Representative, irrespective of other responsibilities, has

responsibility and authority that includes:

a) Ensuring that the processes needed for the Quality Management System are establishedimplemented and maintained.


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b) Reporting to Top Management on the performance of the Quality Management Systemand any need for improvement (Section 5.6).

c) Ensuring the promotion of awareness of customer requirements throughout theorganization (Section 5.5.3)

5.5.3 Internal Communication

We communicate information regarding QMS processes and their effectiveness through

documented training (Section 6.2.2), the internal audit process (Section 8.2.2), continualimprovement and corrective/preventive action processes (Section 8.5), and regular formal and

informal communications as follows:

The Quality Manager posts information on bulletin boards throughout the facility toconvey information regarding customer requirements, and the status and importance of

quality activities. Internal audits (Section 8.2.2) are also used to reinforce or

communicate appropriate information to employees.

The Safety Coordinator posts information on bulletin boards throughout the facility toconvey information regarding the status of the Safety and Environmental Management

Program, and related statutory/regulatory requirements.

The Presidentposts information on bulletin boards throughout the facility to conveyinformation regarding the company, employee benefits, programs, and applicable

statutory/regulatory requirements.

All officers and managers are responsible for establishing internal communications as needed toconvey to their employees the relevance and importance of their activities. Communications

regarding how employees contribute to the achievement of objectives is also conveyed andreinforced during employee performance reviews (Section 6.2.2).

5.6 Management Review

5.6.1 General

Top Management at K-I Machine Tool & Production, Inc. reviews the organizations QualityManagement System once annually as a minimum [more often when directed by the President]

to ensure its continuing suitability, adequacy and effectiveness of our QMS in accordance withprocedures detailed in OP 5.6. This review includes assessing opportunities for improvementand the need for changes to the Quality Management System, including the Quality Policy and

Quality Objectives.

Records from Management Reviews are maintained (see 4.2.4).


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5.6.2 Review Input

The input to Management Review includes information on:

a) Results of Auditsb) Customer Feedbackc) Process performance and product conformityd) Status of preventive and corrective actionse) Follow up actions from previous Management Reviewsf) Changes that could affect the Quality Management System, andg) Recommendations for improvement.

5.6.3 Review Output

The Output from Management Review includes decisions (if any) and actions related to:

a) Improvement of the effectiveness of the Quality Management System and its processesb) Improvement of Product related to customer requirements, andc) Resource needs.

6.0 Resource Management

6.1 Provision of Resources

Top Management at K-I Machine Tool & Production, Inc. determines and provides the resourcesneeded:

a) To implement and maintain the QMS and to continually improve its effectiveness, andb) To enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources (Organization Chart, FC 6.2)

6.2.1 General

Personnel performing work that affects quality are competent to perform such work. They are

judged competent by K-I Machine Tool & Production, Inc. management and supervisory staff

based on education, trainings, skills and/or experience.

6.2.2 Competence, Awareness and Training

K-I Machine Tool & Production, Inc.:

a) Determines the necessary competence for personnel performing work that affects thequality of the product.


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b) Provides training or takes other action to satisfy these needs (OP 6.2.2).c) Evaluates the effectiveness of the actions taken through Reports on performance.d) Ensure that personnel are aware of the relevance and importance of their activities and

how they contribute to the achievement of the quality objectivese) Maintains appropriate records of education, training, skills and experience (see 4.2.4).

6.3 Infrastructure

K-I Machine Tool & Production, Inc. determines, provides and maintains the infrastructure

needed to achieve conformity to product requirements. Infrastructure includes, as applicable:

a) Buildings, workspace and associated utilities.b) Process equipment (both hardware and software)c) Supporting services

6.4 Work Environment

K-I Machine Tool & Production, Inc. determines and manages the work environment needed to

achieve conformity to product requirements.

We provide employee benefits, job and schedule flexibility and involvement of our employees in

an empowered environment of continual improvement (Section 6.2.2). We engender total

participation by involving employees in internal audit (Section 8.2.2) and improvement (Section8.5) activities. The President has overall responsibility for identifying, implementing andmaintaining effective employee benefit and workforce involvement programs. We provide and

maintain a work environment in a state of order, cleanliness and repair consistent with the

product and manufacturing process needs (Section 6.3)

The Safety Coordinator has overall responsibility for identifying, implementing and maintaining

safety and environmental management systems, processes and controls needed to ensure productconformance and meet customer, statutory or regulatory requirements. We monitor and improve

workplace safety, health, and ergonomics through adherence to good manufacturing practices,

and through safety team meetings and training (Section 6.2.2).


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Somchith

Inthabandith

President/Operations Manager

Lin Lin Aung

Quality Manager(Mgmt Rep)

Somchan

Thatsanaphon

Vice President

Chansouk

Inthabandith

Office Manager

Tony Sedbrook

EngineeringReceiving/Shipping

Khompitak

Buddawo

Shop Supervi

FC 6.2

Organization Cha


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7.0 Product Realization

7.1 Planning of Product Realization

Our QMS identifies, plans for and documents our product realization processes to ensure

consistency with all applicable requirements, including customer requirements and related

quality objectives and requirements for specific products and any/all applicable statutory/legal

requirements. These objectives and requirements are determined during Contract Review andare accepted, amended or rejected at that time. Acknowledgements are sent to customers when

required or, when the contract documents are ambiguous. Planning of product realization is

consistent with the requirements of the other processes of the QMS (Section 4.1).

The outputs of product realization planning include the specific methods, facilities, equipment,

people, materials and support services needed to achieve all desired results for a particularproduct, service, or contract. Essentially, the outputs of the quality planning process applicable

to all products are the router, work instructions as required and other data in the job router packs

(Section 7.5.1.2) located in work areas where needed.

The outputs of quality planning (i.e. routers, control plans, etc.) are carried out in accordance

with planned monitoring and measurement activities (Section 8.2), which may also include the

use of appropriate statistical techniques (Section 8.1).

When requirements are not adequately addressed in the standard job pack documentation, or as

required by the customer, the Quality Manager has overall responsibility for developing andimplementing a quality control plan to address additional requirements or controls needed to

verify work for the specific process, product or contract in question.

Records of the quality planning process are maintained (Section 4.2.4).

7.1.1 Advanced Quality Planning. Customer requirements and references to its technical

specifications are included in the planning of product realization as a component of the qualityplan. Some of our customers refer to Advanced Product Quality Planning (APQP) as the means

to achieve product realization. APQP embodies the concepts of error prevention and continual

improvement as contrasted with error detection and is based on a multidisciplinary approach. K-I Machine applies the requirements of product and manufacturing process design to development

of product realization processes through our APQP process.

7.1.1.1 Our APQP/PPAP process provides a consistent advanced product quality planning

process acceptable to many of our customers.

The APQP process (as required) is used by the APQP Team to:

Review special characteristics.

Develop/review failure modes and effects analysis as needed

Establish actions to reduce potential failure modes with high risk

Develop/review control plan


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Report and timely provision of required deliverables (i.e. Tooling, Fixtures, PFMEA,Control Plans, PPAP, Run @ Rate, etc.)

7.1.1.2 Special Characteristics for inclusion in the control plan comply with customer specified

definitions and symbols and other process control documents (including drawings, FMEAs,operator instructions, etc.) that affect product characteristics and process parameters.

7.1.1.3 Production Part Approval Process (PPAP) Team Leaderimplements a production partapproval process for customers that require this process, and in the absence of any specific

instructions, we will default to a level 1 PPAP submission. PPAP approval is obtained prior to

the first production shipment of product (unless specifically waived by the customer).

7.1.2 Change control. The Quality Manager obtains necessary customer approval of quality

plans, acceptance criteria, product and/or manufacturing process, and all related changes thatmay impact product realization. When required by the customer, additional verification and

identification requirements are performed, such as required for new product introduction and

validation. Effective date of all changes shall be communicated back to the customer and is part

of change control.

7.2 Customer-Related Processes

Achieving our quality policy to meet or exceed customer requirements requires that wedetermine, understand, and consistently meet or exceed our customers requirements and

expectations, and that we establish effective communication systems with our customers with

regards to product information, inquiries, contract or order handling and related changes, andcustomer feedback, including complaints. These efforts are described below. The V.P. has

overall responsibility for developing and implementing effective customer-related processes in

accordance with the policies in this section andSection 8.2.1.

7.2.1 Determination of Requirements Related to the Product

Sales personnel lead the generation of quotes/proposals and negotiate final contracts/orders. A

customer order constitutes a contract, and we ensure that the customers requirements are clearly

identified and confirmed prior to acceptance. This includes customer requirements for

documentation, and control of special characteristics, delivery and post delivery activities, allstatutory and regulatory requirements applicable to the product, and any additional requirements

considered by K-I Machine.

7.2.2 Review of Requirements Related to the Product

Sales personnel review customer requirements identified during the determination (P.O. review)

process (Section 7.2.1) to ensure that they are clearly stated, understood, and recorded.

Our process for reviewing all applicable requirements is defined and we ensure:


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a) All applicable product requirements are defined, understood and confirmed with thecustomer prior to acceptance.

b) Manufacturing feasibility of proposed (new or changed) products is investigated,confirmed and documented prior to making a commitment to supply.

c) Contract or order requirements differing from those previously expressed are resolved.

d) Records of the review and actions resulting from the review are maintained (Section4.2.4)

Where product requirements are changed, the Quality Manager ensures relevant documents are

amended and relevant personnel are made aware of the changed requirements.

7.2.3 Customer Communication

K-I Machine determines and implements effective processes for communicating with ourcustomers.

Customers will be provided information and points of contact for the following functions:Management, Sales, Manufacturing, Quality, Engineering and Purchasing.

Customer communications are established through a variety of channels:

Sales provide product information directly to customers including verbal and printed

information on our standard product offerings as well as customized information for

unique customer applications.

Inquiries are handled by our Sales personnel depending on the nature of the inquiry or

who made initial contact (Section 7.2.1). Engineering personnel provide technicalassistance and related information as needed.

We pay particular attention to customer feedback, including customer complaints andcustomer satisfaction. Customer satisfaction is evaluated on an on-going basis by Sales

and Quality personnel (Section 8.2.1).

We maintain a user/customer friendly web site, www.kimachine.com,which containsextensive product information and contact information to be used by both customers and

suppliers.

7.2.3.1 Electronic Data Interchange (EDI)

Some of our customers require EDI methods to be utilized. Any updates, new releases, systemchanges, etc. are communicated to us by our customers.


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7.2.3.2 Advanced Shipping Notification (ASN)

An ASN is the electronic transfer of shipping data to the customer. For specific customers, K-I

Machine utilizes an ASN to facilitate the electronic transfer of data utilized by our customers to:

Determine and confirm goods in transit.

Verify and receive products into their system.

Create an electronic invoice that will generate payment.

7.3 Design and Development

K-I Machine Tool & Production, Inc. has no Design and Development responsibilities. See

exclusion per Section 1.2.

7.3.1 Design and Development Planning

Not Applicable.

7.3.2 Design and Development Inputs

On occasion, K-I Machine is asked for manufacturability inputs during the initial design phase.

If asked, K-I Machine will review and provide feedback to our customers that may be

incorporated into their designs.

7.3.3 Design and Development Outputs

Not Applicable.

7.3.4 Design and Development Review

On occasion, K-I Machine may be asked for manufacturability inputs to be used at the various

design review meetings, as well as may be invited to the review. K-I Machine will accommodate

as needed.

7.3.5 Design and Development Verification

Not applicable.

7.3.6 Design and Development Validation and Customer Acceptance Testing

Many times K-I Machine will be asked to manufacture prototypes that will be used by the

customer to validate the designs. In addition to the prototypes, K-I Machine will provide all

inspection data as defined by the customer.


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7.3.7 Control of Design and Development Changes

The Quality Manager will review and communicate all changes to production and communicate

the effective date of implementation of the change to the customer (Section 7.1.2).

7.4 Purchasing

We work in partnership with our suppliers to ensure that purchased products and services meet

all applicable requirements. The processes applicable to the planning, acquisition and

verification of all products and services that affect customer requirements are defined in OP7.4.1 andOP 7.4.2.

7.4.1 Purchasing Process

The type and extent of control applied to our suppliers and purchased product is dependent uponthe effect on subsequent realization processes and their output, as well as consideration of other

characteristics including:the type of product; the potential impact of the product on our

processes, products, or services; the results of supplier evaluations; and past performance.Purchased products are verified (Section 7.4.3 andSection 8.2.4) to ensure conformity to

specified purchase requirements (Section 7.4.2) and conformity to applicable regulatory

requirements.

The Purchasing Specialist defines and documents the supplier approval process, and periodic

evaluation; OP 7.4.1. Suppliers are evaluated and selected based on their ability to supply

products or services in accordance with our requirements.

7.4.1.1 Supplier quality management system development. Essentially, the same requirements

imposed on K-I Machine, are cascaded down to oursupply base. In order to ensure the qualityof the parts shipped by K-I Machine, we have established systems to manage the parts and

materials received from our supply base and initiate supplier development based on importance

of the supplied product and supplier quality performance in accordance with supplierexpectations and monitoring procedures defined in OP 7.4.1.

7.4.1.2 Customer-approved sources. Where specified (by contract, customer engineeringdrawing, or specification) we purchase products, materials or services from customer-approved

sources.

A master list of approved suppliers (ASL) is maintained to ensure we only purchase productfrom K-I Machine qualified sources or customer-approved sources. The results of evaluations

and follow/up actions are recorded.

Supplier performance is monitored by the Purchasing Specialist perOP 7.4.1 through one or

more of the following indicators: delivered product quality, delivery schedule performance,

pricing, communication and technology.


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7.4.2 Purchasing Information

The Purchasing Specialist ensures the adequacy of specified purchase requirements prior to

communication to the supplier per procedures defined in OP 7.4.2and the following policies:

Purchasing information communicated to our suppliers contains the appropriate data needed to

clearly and fully describe requirements for purchased materials and services; including, whereappropriate, requirements for approval/qualification of product, certifications, procedures,

processes/systems, equipment; qualification of personnel; and quality management system

requirements.

7.4.3 Verification of Purchased Product

The Quality Manager ensures that purchased product is verified prior to use or release inaccordance with provision of this section.

7.4.3.1Incoming Product Quality. The Quality Manager has overall responsibility for ensuringthe quality of purchased products using one or more of the following methods: receipt andevaluation of statistical data; receiving inspection and/or testing; second or third party audits of

supplier sites (when coupled with records of acceptable delivered product quality); part

evaluation by a designated laboratory; and/or another method agreed with the customer.

The Quality Manager plans and implements appropriate sampling plans and/or other statistical

techniques, as required, to verify purchased product perSection 8.1.

All requirements for approval of purchased product and/or supplier procedures, processes,

equipment, personnel, and/or quality systems are reviewed for adequacy prior to communication

to the supplier perSection 7.4.2.

As applicable, the Quality Manager documents and communicates the intended verification

arrangements and method of product release related to verification activities performed at oursuppliers premises.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

We utilize a process-focused approach to plan and control operations. Our initial focus is toassure the quality of process inputs - that is, employees, material, facilities and equipment, and

methods. Employees must be equipped to perform the process properly through appropriate

education and training. Material must meet specified requirements and be properly identified,stored, and issued. Equipment and facilities must be adequate, accurate, available and properly

utilized. Routers, work instructions and other important data must be current and correct.

Methods must be appropriate and proven capable of accomplishing the desired results. The


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appropriateness of all these fundamental process inputs must be assured, and processes must bemeasured, monitored and controlled to assure effectiveness and/or to identify opportunities for

improvement.

Information inputs to the process include product characteristics and appropriate routers and/or

work instructions containing specific work methods and/or other pertinent information, including

process monitoring and verification instructions and criteria developed during product qualityplanning (Section 7.1) and/or manufacturing process development. The Operation Manager,

ensures that all appropriate information including final product specifications, raw material

characteristics and the required product parameters, is provided to production personnelthroughout the production process. Such information is provided through job schedules/plans,

production team meetings, work instructions posted in areas where they are needed, and/or

through job specific information included in individual job packs (including control plans, where

applicable).

7.5.1.1 Control plan and/or router. Where required, The Quality Manager, perSection 7.1.1:

Develops control plans for the product supplied Develops a control plan for pre-launch and production that takes into account the design

FMEA and manufacturing process FMEA outputs.

Ensures that production across all shifts is staffed with personnel in charge of ordelegated responsibility for product quality.

The Quality Manager further ensures that control plans or routers:

List the controls used for manufacturing process control

Include methods for monitoring of control exercised over special characteristics defined

by both K-I Machine and the customer Include customer-required information, if any

Initiate the specified reaction plan (Section 8.2.3.1) when the process becomes unstableor not statistically capable

Are reviewed and updated when any change occurs affecting product, manufacturingprocess, measurement logistics, supply sources or FMEA (Section 7.1.3)

Are approved by the customer after K-I Machine review/update (as required)

7.5.1.2 Router/Work instructions. For many of our products, a router is sufficient to providework instructions for the employees. Where necessary, the Operations Manager prepares

appropriate work instructions for all employees having responsibility for processes that impact

product quality and/or employee safety (Section 6.4.1). The instructions are derived fromsources such as the purchase order, customer specifications, the control plan and the productrealization process and are accessible to the work areas where they are needed.

7.5.1.3 Verification of job set-ups. Job set ups are verified prior to commencing each newproduction run and/or when process changes are made; Section 8.2.4. Work instructions

governing set ups and related verifications are developed and available, and use statistical

methods of verification where applicable.


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7.5.1.4 Preventive and predictive maintenance. PerSection 6.3.1, the Operations Manageridentifies key process equipment, provides resources for their maintenance and develops an

effective total preventive maintenance system that at a minimum, includes:

Planned maintenance activities Packaging and preservation of equipment, tooling, and gauging,

Availability of replacement parts for key manufacturing equipment

Documenting, evaluating, and improving maintenance objectives.

7.5.1.5 Production scheduling. The Operations Manager schedules production to meet customer

requirements and our goal to achieve 85% on-time delivery performance through K-I Machines

production control system that provides production information at key stages of product

realization.

7.5.1.6 Equipment. The Operations Manager ensures the suitability and availability of all

equipment, facilities and tooling used for production operations; Section 6.3.

7.5.1.7 Monitoring and Measurement Devices. The Quality Manager ensures that monitoring and

measurement devices capable of meeting our measurement requirements are available for useduring production; Section 7.6.

7.5.1.8 Monitoring Activities. The Operations Manager ensures that production personnelmonitor the quality of their own work and understand the procedures for reporting related

problems and/or suspected nonconforming conditions; Section 8.2.3.1. The Quality Manager is

responsible for planning and implementing in-process inspections needed to ensure process

control and product quality.

7.5.1.9 Release, Delivery, and Post-Delivery Processes. Release of product is dependent on its

compliance with all technical specificationsand its ability to meet additional customerrequirements including packaging, shipping, and delivery, as identified in the contract or order.The President, through the Purchasing Specialist, the Operations Manager, and the Quality

Manager, ensures that records of product approval are maintained and clearly indicate the

authorizing employee; Section 7.5.3.

The Operations Manager periodically reviews operational data as well as progress towards

achievement of corporate level product/service performance objectives (Section 5.4.1) andprovides related recommendations for review by Top Management; Section 5.6.1.

7.5.2 Validation of Processes for Product and Service Provision

K-I Machine Tool & Production, Inc. validates all processes for product and when required by

contract any service provision where subsequent monitoring or measurement cannot verify the

resulting output (Section 7.5.1). This includes any processes where deficiencies becomeapparent only after the product is in use or the service has been delivered.


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Validation shall demonstrate the ability of these processes to achieve planned results.

K-I Machine Tool & Production, Inc. will establish arrangements for these processes to achieve

planned results through:

a) Defined criteria for review and approval of the processes with routes and/or work orders,written and verbal; work instructions, such as prints and specifications.

b) Approval of equipment and qualification of personnel. All equipment is selected by theOperations Manager and is maintained through preventive maintenance programs;

verified on the coolant and lubricant maintenance log and verified though maintenanceinvoices. Personnel that can impact product quality are provided with on the job training

and are evaluated and determined competent before they can operate unsupervised, by

top management.

c) Use of specific methods and procedures, as found in the process flow/control plans.d) Requirements for records (Section 4.2.4), ande) Revalidation and testing after changes have been implemented.

7.5.3 Identification and Traceability

The Production and Quality Manager has overall responsibility for establishing and maintainingproduct identification throughout all stages of production and delivery. Where product traceability

is a customer-specified requirement, appropriate controls and records are established and

maintained.

We establish and maintain product monitoring and measurement status through the use of both

physical identification tags/labels and electronic records. Additionally, physical location in

clearly designated hold area is an indicator of product status; however, physical location inproduction process areas may serve as an indicator of product status only where product

identification and inspection status is inherently obvious.

The President, through the Purchasing Specialist, the Operations Manager and the Quality

Manager, ensures that all incoming, in-process, and final product is suitably identified.

Where contractually required, the Quality Manager plans for, establishes and maintains

appropriate traceability records in accordance with customer requirements; Section 7.1. At a

minimum, where products are made in lots or batches we identify and record a unique lot or

batch number and related information on the job traveler; Section 7.5.1.

7.5.4 Customer Property

Customer property includes customer-owned material, tools (including returnable packaging),

tooling (including test/inspection tooling and equipment), and intellectual property. We identify,

verify, protect and maintain customer property provided for use or incorporation into theproduct, by applying the same process controls as we do to purchased product (Section 7.4).


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Whenever customer-specified requirements for property management are beyond the control orcapability of our established QMS, the Quality Manager has overall responsibility for planning,

documenting and communicating such requirements to all appropriate personnel as a part of

product quality planning (Section 7.1).

All customer-owned production tooling is permanently marked so the ownership of each item is

visible and can be determined. The Quality Manager ensures that lost, damaged or unsuitablecustomer property is recorded and immediately reported to the customer (Section 8.3.3).

7.5.5 Preservation of Product

The President, through the Purchasing Specialist, Operation Manager, Quality Manager, and

Safety Coordinator, has overall responsibility for establishing and implementing a material

management system to ensure product conformity is preserved during internal processing anddelivery to the intended destination. This system includes the identification, handling, storage,

packaging, delivery, and protection of final product as well as raw materials and in-process

constituents of the final product.

In order to detect deterioration, the condition of stock is periodically assessed. K-I Machine uses

an inventory management system based on first-in-first-out (FIFO).

7.6 Control of Monitoring and Measuring Devices

The Quality Manager is responsible for establishing and maintaining an effective system for

identifying, selecting and controlling the use of monitoring and measuring devices used to

provide evidence of product conformance to established requirements. These controls, defined inOP 7.6, apply to K-I Machine-owned, customer-owned and employee-owned devices.

We determine the measurements to be made and the accuracy required to assure conformity ofour product to specified requirements. We identify and select monitoring and measuring devices

and verify their capability of meeting such requirements prior to use.

Monitoring and measuring devices are used and controlled in a manner that ensures continuing

suitability; this includes ensuring that the environmental conditions are suitable for the

calibration, inspections, measurements and tests being carried out. We also define the processes

employed for the on-going calibration, control and maintenance of monitoring and measuringdevices including their identification, location, frequency/method of checks, uses/acceptance

criteria and the action to be taken when results are unsatisfactory.

All monitoring and measuring devices that can affect product quality are identified and

calibrated at prescribed intervals in accordance with standards traceable to NIST. Where no such

standards exist, the basis used for calibration is documented. K-I Machine, Inc. does not have aninternal laboratory facility and therefore cannot perform all required inspections, tests and/or


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calibrations; accordingly, external laboratories used for inspection, test or calibration services areselected, qualified and monitored perSection 7.4.

When monitoring and measuring devices are found to be out of calibration (or when calibrationstatus is not known), they are adjusted or re-adjusted as necessary and the validity of previous

measuring results is documented.

All monitoring and measuring devices are safeguarded from adjustment that would invalidate the

calibration.

All monitoring and measuring devices are handled, maintained and stored in a manner that

ensures accuracy and fitness for use is maintained.

7.6.1 Measurement systems analysis. Statistical studies are conducted to analyze the variationpresent in the results of each type of measuring and test equipment system (when referenced in

the applicable control plan). Such measurement systems analyses conform to applicable

customer reference manuals or requirements; other analytical methods and acceptance criteriaare only used if approved by the customer; see OP 7.6.

7.6.2 Calibration/verification records. Records of the calibration/verification activity for allgauges, measuring, and test equipment needed to provide evidence of product conformity to

determined requirements, including employee and customer owned equipment, includes:

Equipment identification, including the measurement standard against which theequipment is calibrated

Revisions following engineering changes

Any out-of-specification readings as received for calibration/verification An assessment of the impact of an out-of-specification condition

Statements of conformance to specification after calibration/verification Notification to the customer if suspect product or material has been shipped

8.0 Measurement, Analysis and Improvement

8.1 General

Management at K-I Machine Tool & Production, Inc. has planned and implemented themonitoring, measurement, analysis and improvement processes needed to:

a) Demonstrate conformity to product requirementsb) Ensure conformity of the QMSc) Continually improve the effectiveness of the QMS through the achievement of the stated

objectives and continuous improvement programs as outlined in the QMS.


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8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

Customers are the reason we exist and drive our quality policy to meet or exceed customer

requirements. The V.P. has overall responsibility for identifying and reviewing customer

requirements (see Section 7.2.1 andSection 7.2.2) and for monitoring and measuring customersatisfaction per procedures contained in OP 8.2.1, summarized as follows:

Data collected by customer contact personnel during routine communications (Section 7.2.3)provide our primary basis for assessing customer satisfaction. In addition, Sales personnel utilize

a very simple customer satisfaction survey form to determine the customers overall perception

of how well we are meeting their requirements and to document any recommendations for

improvement.

At a minimum, related performance indicators include, but are not limited to:

Delivered part quality performance

Delivery schedule performance

Timeliness of Quotes

Pricing

Packaging Customer Service

Customer complaints (whether received in writing, verbally or electronically) are immediately

forwarded to the V.P. for appropriate action. If the V.P. cannot resolve the issue to the

customers satisfaction, then the complaint is transferred to the President for assignment toanother appropriate manager or function for resolution. Customer complaints are documented

and monitored through resolution through our continual improvement system (Section 8.5).

The V.P. periodically reviews customer satisfaction survey data and other customer feedback

(including complaints), as well as progress towards achievement of corporate level customer

satisfaction improvement objectives (Section 5.4.1) and provides related recommendations for

review by Top Management (Section 5.6).

8.2.2 Internal Audit

K-I Machine Tool & Production, Inc. conducts scheduled internal audits to determine whetherthe Quality Management System:

a) Conforms to the planned arrangements (see 7.1), to the requirements of ISO 9001:2008Standard and to the QMS requirements established by K-I Machine Tool & Production,

Inc. andb) Is effectively implemented and maintained.


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K-I Machine Tool & Production, Inc. plans its audit program. It takes into consideration thestatus and importance of the processes and areas to be audited, as well as the results of previous

audits. The audit criteria, scope, frequency and methods are defined in the audit schedule

maintained by the Management Representative. The OP 8.2.2 spells out the methodology for theInternal Audit Program at K-I Machine. Selection of auditors and the conduct of audits ensure

the objectivity and impartiality of the audit process. Auditors do not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting

results and for maintaining records (Section 4.2.4) are defined in OP 8.2.2.

The management responsible for the area being audited will ensure that actions are taken without

undue delay to eliminate detected nonconformities and their causes. Follow-up activities will

include the verification of the actions taken and the reporting of verification results (Section8.5.2). Audit non-conformances are to be addressed by the supervisor in charge of the area in atimely manner (within two weeks is our goal). Follow up activities verifying the effectiveness of

the corrective action will continue until the cause(s) of non-conformance are eliminated or

reduced to a level where further action is unnecessary.

8.2.3 Monitoring and Measurement of Processes

We apply suitable methods for monitoring and measuring all QMS processes. At a minimum,

managers with overall responsibility for carrying out a QMS process, analyzes process

performance (Section 8.4) and takes appropriate improvement, corrective or preventive action

(Section 8.5).

We conduct procedural and process audits (Section 8.2.2) to verify QMS process conformance

and identify opportunities for improvement; manufacturing process audits are conductedannually.

As required we monitor and measure manufacturing processes to ensure continuing processcapability and suitable performance when specified by the customer part approval process

(PPAP) requirements.

Process Capability. As part of manufacturing process design the Quality Manager ensures

process studies, where applicable, are performed on all new product realization processes to

verify process capability and provide additional input for process control. Process capability

study results, where applicable, and specifications are documented. Acceptance criteria andappropriate reaction plans are included in control plans (Section 7.5.1.1) and/or job packets

(Section 7.5.1).

Job Set Up. Job set ups (Section 7.5.1.3) are verified (Section 8.2.4) prior to commencing each

new production run and when process changes are made.

Process Monitoring. Processes are monitored by process operators per applicable instructions

(Section 7.5.1.2) and procedures. Control plans and process flow diagrams, as applicable, are


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implemented (Section 7.5.1.1) to ensure adherence to the specified measurement techniques,sampling plans, acceptance criteria, and reaction plans when acceptance criteria is not met; see

Section 7.1.1 andSection 8.1. Production personnel follow documented reaction plans when

processes become unstable or no longer capable. The Quality Manager then initiates a correctiveaction plan indicating the specific timing and assigned responsibilities to assure the process

becomes stable and capable. As required, the corrective action plan is reviewed with and

approved by the customer and usually requires application of a customer recognized or approvedproblem solving approach (Section 8.5.2).

8.2.4 Monitoring and Measurement of Product

The Quality Manager has overall responsibility for planning (Section 7.1) and implementing

inspection activities needed to verify product requirements are met at appropriate stages of the

product realization process in accordance with the applicable control plan or router. Whenselecting product parameters to monitor compliance to internal and external requirements,

product characteristics are determined leading to the types of measurement, suitable

measurement means, and the required capability and inspection skills needed.

The scope of our product monitoring and measurement system includes receiving inspection, in-

process inspection, final inspection, and special consideration regarding monitoring andmeasurement of appearance items.

Receiving Inspection. Incoming product is not used or processed until it has been inspected or

otherwise verified as conforming to specified requirements in accordance with the control plan,router, and/or documented procedures. Methods used to verify incoming product (Section 7.4.3)

may include: receipt and evaluation of statistical data by the supplier; formal receiving

inspection and/or test evaluation by accredited laboratories; or source inspections.

In-process Inspection. Formal in-process inspections are performed by Quality Control

personnel in accordance with the control plan and/or router as applicable.

Final Inspection and Test. All finished products and completed services are verified by final

inspections specified in the control plan and/or router as applicable.

Evidence of Conformity. Inspection records are maintained for a minimum of three years. These

records include final inspection authority and identify and confirm that all critical parameters are

in accordance with established requirements and specifications.

Product Release and Delivery. Product is not normally released or delivered until all plannedinspections and tests have been completed, and records have been maintained providing evidenceof conformity with acceptance criteria and identifying the person(s) authorizing release. In rare

cases (due to customer demands and/or production emergencies) unverified product may be

released or delivered under controlled conditions and authorized by the Quality Manager and,where applicable, approved by the customer. Nonconforming (or suspect) product is identified

and controlled to prevent its inadvertent use (Section 8.3).


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8.3 Control of Nonconforming Product

The Quality Manager has overall responsibility for implementing an effective process for

identifying, documenting, segregating, evaluating, and disposing of nonconforming product.

A documented procedure, OP 8.3, has been created to deal with nonconforming product by one

or more of the following ways;

a) Taking action to eliminate the detected nonconformityb) Authorizing its use, release or acceptance under concession by a relevant authority, and

where applicable, by the customer

c) Taking action to preclude its original intended use or applicationd) Taking appropriate actions after the nonconforming product is detected after delivery or

use has started

After non-conforming product has been corrected, it is subjected to re-verification to

demonstrate conformity to the requirements.

Records of the nonconformities and actions taken, including concessions obtained, shall be

maintained (see 4.2.4).

8.4 Analysis of Data

K-I Machine Tool & Production, Inc. will determine, collect and analyze appropriate data todemonstrate the suitability and effectiveness of the QMS and to evaluate where continual

improvement of the effectiveness of the QMS can be made. This will include data generated as a

result of monitoring and measurement and from other relevant sources.

The analysis data will provide information relating to

a) Customer satisfaction (Section 8.2.1); this can take the form of questionnaires sent tocustomers, interviews with customers by the president or anecdotal data provided to K-I

Machine Tool & Production, Inc..b) Conformity to product requirements (Section 7.2.1)c) Characteristics and trends of processes and products including opportunities for

preventive action, and

d) Suppliers.

8.5 Improvement

8.5.1 Continual Improvement

K-I Machine Tool & Production, Inc. will continually improve the effectiveness of the QMSthrough the use of the quality policy, quality objectives, audit results, analysis of data, corrective

and preventive actions and management review.


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Exceptions to the objectives are discussed with on-going action plans to achieve timeliness of

delivery and the implementing action plans leading to elimination of Customer Returns /

Complaints so that achievement of these goals become a reality at K-I Machine Tool &Production, Inc.

8.5.2 Corrective Action

Evidence of nonconforming product, customer dissatisfaction, or ineffective processes is used to

drive our corrective action system because a problem exists, requiring immediate correction andpossible additional action aimed at eliminating or reducing the likelihood of its recurrence.

Management with responsibility and authority for corrective action are notified promptly of

product or process non-conformities. Investigating and eliminating the root cause of these

failures is a critical part of our continual improvement process. Requirements defined in ourcorrective action procedure (OP 8.5.2) include:

a) Review of non-conformities (including customer complaints)b) Determination of the causes of non-conformitiesc) Evaluating the need for action to ensure that non-conformities do not recurd) Determination and implementation of action needede) Records of the results of action takenf) Review of the effectiveness of the corrective action taken

Follow-ups are conducted (through the internal audit process; Section 8.2.2) to ensure thateffective corrective action is taken appropriate to the impact of the problem encountered. In

addition, the Quality Manager summarizes and analyzes corrective action data to identify trends

needed to assess overall effectiveness of the corrective action system and to develop relatedrecommendations for improvement. The corrective action system is considered effective if

specific problems are corrected and data indicates that the same or similar problems have not

recurred. Results of this analysis are recorded (Section 4.2.4) and related recommendations arepresented to Top Management for review and action during management reviews (Section 5.6).

8.5.3 Preventive Action

Data from internal audits, customer feedback, employee suggestions, and other appropriate data

is collected and analyzed (Section 8.4) to identify the actions needed to eliminate the causes of

potential problems and thereby prevent their occurrence. Investigating and eliminating the rootcause of potential failures is a critical part of our continual improvement process. We review

and initiate preventive actions through our preventive action procedure (OP 8.5.3). We applycontrols and follow-up to ensure that effective preventive action is taken appropriate to the riskand impact of potential problems and losses. The preventive action system is considered

effective if potential losses were avoided. Results of this analysis are recorded (Section 4.2.4)

and related recommendations are presented to Top Management for review and action duringmanagement reviews (Section 5.6).


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Appendix A

List of Key Internal QMS Documents Referenced in this Manual

Document No. Title

QM Quality Manual

PFC 4.1 QMS Processes Flow Map

OP 4.2.3 Control of DocumentsOP 4.2.4 Control of Records

FC 6.2 Organization Chart

OP 6.2.2 TrainingOP 5.6 Management Review

OP 7.4.1 Supplier Evaluation

OP 7.4.2 PurchasingOP 7.6 Control of Monitoring and Measuring Devices

OP 8.2.1 Customer Satisfaction

OP 8.2.2 Internal AuditOP 8.3 Control of Nonconforming Product

OP 8.5.2 Corrective Action

OP 8.5.3 Preventive Action


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Appendix B

Terms and Definitions

Acronyms:

FC Flowchart

OP Operating ProcedurePFC Process Flowchart

QMS Quality Management System

WI Work InstructionsTI Training Instructions

Product This term also means service

Terms and Definitions. Terms and definitions contained in this manual and unique to our

organization or business are listed below. Customer definitions will take precedence over all

other definitions.