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QM00001 Rev. D

QUALITY MANAGEMENT SYSTEM MANUAL

__________________ ________ __________________ ______ Alan Kalman, President Date Quality Department Manager Date

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QM00001 Rev. D

1.0 INTRODUCTION

The purpose of this Quality Manual is to ensure that activities of the employees of Kalman Manufacturing, Inc. are directed and controlled in order to exceed our customers’ expectations of the products and services we provide them. The Quality Policies within this manual are initiated and maintained by Kalman Manufacturing’s top management. These policies are continually reviewed and updated to address the changing requirements of our customers and our business. Kalman Manufacturing is a high-precision manufacturer of CNC machined products, supplying a diverse customer base that ranges from medical to global positioning systems companies. The Quality Management System defined herein is designed to fulfill the regulatory requirements set forth in the following standard:

ISO 9001:2008 It is applied to the activities within Kalman Manufacturing as they pertain to the design, development, manufacturing, and distribution of its products.

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2.0 TABLE OF CONTENTS

Section Page

1.0

Introduction 2

2.0 Table of Contents 3

3.0 Company Background and Overview 4

4.0 Quality Management System 6

5.0 Management Responsibility 8

6.0 Resources Management 11

7.0 Product Realization 13

8.0 Measurement, Analysis, and Improvement 18

9.0 Standard Operating Procedures Index 22

SOP# ISO9001:2008 Clause

Title

OP00000 4.0, 4.1 Quality Management System 6

OP00001 4.2, 4.2.1, 4.2.2, 4.2.3, 4.2.4 Document Control 6-7

OP00002 4.2.4 Control of Records 7

OP00003 5.6 Management Review 10

OP00004 6.2.2, 6.3 Training 11

OP00005 6.3, 6.4 Safety and Work Environment 12

OP00006 7.2, 7.2.1, 7.2.2 Sales Order Processing/ Contract Review 13-14

OP00007 7.4, 7.4.1, 7.4.2 Purchasing 14-15

OP00008 7.4.3 Verification of Purchased Product 15

OP00009 6.3, 7.5, 7.5.3, 7.5.4, 7.5.5 Production and Service Provision 15-16

OP00010 7.5.5 Handling, Storage, Packaging, Preservation and Delivery 16

OP00011 7.6 Control of Measurement Equipment 16-17

OP00012 8.2, 8.2.1, 8.2.2, 8.2.3, 8.2.4 Monitoring and Measurement 18-19

OP00013 8.2.2 Internal Audit 18

OP00014 8.2.3, 8.2.4 Monitoring and Measurement of processes 19

OP00015 8.3 Control of Nonconforming Product 19

OP00016 8.4 Analysis of Data 20

OP00017 8.5.1 Continual Improvement 20

OP00018 8.5.2, 8.5.3 Corrective and Preventive Action 20-21

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3.0 COMPANY BACKGROUND AND OVERVIEW

Kalman Manufacturing is a high-precision manufacturing company that specializes in CNC machined products for a wide variety of industries. The Company works closely with its customers to develop a process and plan products from prototypes to production. Kalman Manufacturing was founded in 1985 and currently operates from its 35,000 sq. ft. location in Morgan Hill, California. The Company’s ultimate goal is to achieve the highest levels of quality, customer service, reliability, and cost value, while maintaining growth and enhancing long-term profitability. These attributes will be reached through continual improvement of the Company’s processes and capabilities, and by adhering to the objectives below. As such, it is Kalman Manufacturing’s mission to provide high-quality products and unparalleled customer service at competitive prices. The objectives of Kalman Manufacturing are as follows:

Maintain an effective management and quality system in the form of an ISO 9001:2008 compliant Quality Management System.

Remain the best value to our customers by continuously improving our capabilities

and processes.

Completely satisfy our customers by producing and providing the highest quality products on time, with no rework necessary, and at a competitive price.

Satisfy or exceed the specified requirements of our ever-increasing customer base.

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3.1 Organizational Structure

3.2 Process Work Flow

CustomerInquiries

Check product

inventory

Yes

No

Is the product

outsourced?

ReceivingInspection

Outside Product

Process (if necessary)

Final Inspection

Shipping

CustomerSatisfaction

Quality Objectives

P.O. Issued to approved Vendor

ProductionQuoteIssued

QuoteReceived

from approved Vendor

P.O.from

Customer Received/Reviewed

QuoteIssued

to Customer

P.O. Received/Reviewed

President

FinanceH/R

Customer Service

GeneralManager

Outside Sales

Quality Department

Process Scheduling

Shipping Receiving

Purchasing ManufacturingProduction

EngineeringProgramming

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QM00001 Rev. D

4.0 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements Kalman Manufacturing has established, documented, implemented and currently maintains a quality management system. We continually improve its effectiveness in accordance with the requirements of ISO 9001:2008. A documented procedure (OP00000) is available. The Company:

has determined the processes needed for the quality management system and their application throughout the organization,

determined the sequence and interaction of these processes, determined criteria and methods needed to ensure that both the operation and

control of these processes are effective, ensures the availability of resources and information necessary to support the

operation and monitoring of these processes, monitors, measures and analyzes these processes, and implements actions necessary to achieve planned results and continual

improvement of these processes. These processes are managed by Kalman Manufacturing in accordance with the requirements of ISO 9001:2008. When Kalman Manufacturing chooses to outsource any process that affects a product’s conformity with requirements, the Company ensures control over such processes. Controls of such outsourced processes are identified within the quality management system.

4.2 Documentation Requirements

4.2.1 General The quality management system documentation includes:

documented statements of a quality policy and quality objectives a quality manual documented procedures required by ISO 9001:2008, including Document

Control, Record Control, Internal Audit, Control of Non-conforming Product, Corrective and Preventive Action

documents needed by the organization to ensure the effective planning, operation and control of its processes

records required by ISO 9001:2008

4.2.2 Quality Manual Kalman Manufacturing has established and currently maintains a quality manual that includes:

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the scope of the quality management system, including the details of and justification for any exclusions

the documented procedures established for the quality management system, or reference to them

a description of the interaction between the processes of the quality management system

The Quality Department is responsible for the control of the quality manual.

4.2.3 Document Control Documents required by the quality management system are controlled. Records are a special type of document and are controlled according to the requirements given in section 4.2.4. The Quality Department is responsible for maintaining and controlling documents. A documented procedure (OP00001) has been established to define the controls needed:

to approve documents for adequacy prior to issue to review, update, and re-approve documents as necessary to ensure changes and the current revision status of documents are identified to ensure relevant versions of applicable documents are available at points of

use to ensure documents remain legible and readily identifiable to ensure documents of external origin are identified and their distribution

controlled when needed to prevent the unintended use of obsolete documents, and to apply suitable

identification to them if they are retained for any purpose The Quality Department designate is responsible to control the Document Control Procedure, to ensure relevant versions are available at points of use, to remove obsolete documents, and to control external documents. Documents are reviewed and approved, including re-approval as required, by the appropriate functional manager along with the Quality Department and Company President, if needed.

4.2.4 Control of Records Records are established and controlled to provide evidence of conformity to requirements and the effective operation of the quality management system. Records are legible and readily identifiable and retrievable. A documented procedure (OP00002) has been established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. The Document Control Manager or Quality Department is responsible for controlling the Records Control Procedure.

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5.0 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment Top management, such as the Quality, Purchasing, and Planning Departments and the Company President, can provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:

communicating the importance of meeting customer, as well as statutory and regulatory, requirements to the organization

establishing the quality policy ensuring quality objectives are established conducting management reviews ensuring the availability of resources

Top management is considered to be the Quality Steering Team, which includes the following members: the Quality Department, Purchasing/Planning Department, Production Department, Customer Service, and the Company President.

5.2 Customer Focus

Top management representatives of the Customer Service and Quality Departments ensure customer requirements are determined and are met with the aim of enhancing customer satisfaction.

5.3 Quality Policy

The Quality Department and the Company President ensure the quality policy: is appropriate to the purpose of the organization includes a commitment to comply with requirements and continually improve

the effectiveness of the quality management system provides a framework for establishing and reviewing quality objectives is communicated and understood within the organization is reviewed for continuing suitability

The stated quality policy is as follows:

Kalman Manufacturing is committed to providing products of the highest-quality to our customers on time. Through continuous improvement of our processes, it is our objective to be the best valued supplier to our customers.

Our Quality Management System ensures consistency in all aspects of our operation and the quality of our products. Kalman Manufacturing’s top management continuously supports and provides direction to reach this goal.

We operate our business according to these principles:

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Continually improve our processes and make the best use of our resources in quality-related concerns.

Ensure our activities are safe for all employees and associates. Communicate our quality objectives and our performance against these

objectives throughout the company and to interested parties. Train our employees in the requirements of our Quality Management System

and the Quality Department. Work closely with our customers and suppliers to establish and maintain the

highest possible quality standards. Comply with all applicable Federal and State laws and regulations.

Our Quality Objectives:

Quality Objective Measurement The quality management system established and implemented shall meet and/or exceed the quality system requirements of ISO9001-2008

Maintenance of 3rd Party Registration (QAS International)

We shall encourage open communication with our customers in order to continually understand and meet their needs.

Established SOP Quality Procedures

We aim to provide our customers with 100% satisfaction by supplying them with high quality products and services at a reasonable price.

Maintain and review Customer Satisfaction and Customer Complaint records at Management Review meetings.

The corrective action process will be thorough and effective in resolving issues.

QSP 8.5.2- Corrective Action shall be Maintained and Audited Per QSP 8.2.2 Internal Audit

Management will continuously support and provides direction to reach our goals.

QSP 5.1- Management Review meetings will be held and minutes recorded.

The Quality Department is responsible for ensuring the quality policy is reviewed during the Management Review process.

5.4 Planning

5.4.1 Quality Objectives

Top management of the Quality Department ensures quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the Company. The quality objectives are measurable and consistent with the quality policy. The Quality Department is responsible for establishing and maintaining the quality objectives.

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5.4.2 Quality Management System Planning The Quality Department ensures:

the planning of the quality management system is carried out in order to meet the requirements given in section 4.1, as well as the quality objectives

the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority The Quality and Customer Service Departments ensure responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management Representative Top management and the Quality Department have appointed a member of management who, irrespective of other responsibilities, has responsibility and authority that includes:

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

reporting to the Quality Department and Company President on the quality management system’s performance and any improvements needed

promoting awareness to customer requirements throughout the organization The appointed management representative is the Quality System Manager. This person serves as the liaison to external parties on matters concerning the quality system.

5.5.3 Internal Communication Top management of the Quality, Purchasing, and Customer Service Departments ensure appropriate communication processes are established within the Company and communication takes place regarding the effectiveness of the quality management system.

5.6 Management Review

Top management reviews the Company’s quality management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews are controlled by the Quality Department. A documented procedure (OP00003) has been established for Management Reviews. The input to management review includes information regarding:

results of audits customer feedback

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process performance and product conformity status of preventive and corrective actions follow-up actions from previous management reviews changes that could affect the quality management system recommendations for improvement

The output from the management review includes:

any decisions and actions related to improvement of the effectiveness of the quality management system and its processes

improvement of product related to customer requirements resource needs

The following functional departments attend Management Reviews: the Quality Department, Purchasing/Sales Department, Production Department, and the Company President.

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6.0 RESOURCES MANAGEMENT

6.1 Provision of Resources Kalman Manufacturing management determines and provides the resources needed to implement and maintain the quality management system, continually improve its effectiveness and enhance customer satisfaction by meeting customer requirements.

6.2 Human Resources

6.2.1 General Personnel who perform work affecting conformity to product requirements are deemed competent on the basis of appropriate education, training, skills and experience. The Human Resources, Quality, and Customer Service Departments are responsible for assessing this competence.

6.2.2 Competence, Training and Awareness A documented procedure (OP00004) has been established for employee training. Kalman Manufacturing:

determines the necessary competence for personnel who perform work affecting conformity to product quality

provides training or take other actions to satisfy these needs when applicable evaluates the effectiveness of the actions taken ensures personnel are aware of the relevance and importance of their

activities and how they contribute to the achievement of the quality objectives maintains appropriate records of education, training, skills and experience

The Human Resources, Quality, and Customer Service Departments are responsible to determine competency requirements and to oversee the training process. The Human Resources and Quality Departments also control appropriate records of education, training, skills, and experience.

6.3 Infrastructure

Kalman Manufacturing determines, provides and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable:

buildings, workspace and associated utilities process equipment (both hardware and software) supporting services (such as transport , communication and information

systems)

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6.4 Work Environment

6.4.1 Kalman Manufacturing’s excellence is defined as operational activities that ensure product quality and reliability using documented procedures and work instructions. A documented procedure (OP00005) has been established.

6.4.2 Kalman Manufacturing also takes pride in providing employees the proper training in their own job, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, weather as well as Safety Training.

Kalman Manufacturing determines and manages the work environment needed to achieve conformity to product requirements. The Facilities Department is responsible to identify and control work environment requirements.

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7.0 PRODUCT REALIZATION

7.1 Planning of Product Realization Kalman Manufacturing plans and develops the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system. In planning product realization, the Company determines the following, as appropriate:

quality objectives and requirements for the product the need to establish processes, documents, and provide resources specific to

the product required verification, validation, monitoring, inspection and test activities

specific to the product and the criteria for product acceptance measurement records needed to provide evidence that the realization

processes and resulting product meet requirements The output of this planning is in a form suitable for the Company’s method of operations.

The Planning/Sales and Production Departments are responsible for planning production or service provision and for maintaining associated records.

7.2 Customer-Related Processes

A documented procedure (OP00006) has been established for sales order processing and contract reviews.

7.2.1 Determination of Requirements Related to the Product Kalman Manufacturing determines:

requirements specified by the customer, including the requirements for delivery and post-delivery activities

requirements not stated by the customer but necessary for specified or intended use, where known

statutory and regulatory requirements applicable to the product any additional requirements determined by the organization

The Sales, Quality, and Production Departments are responsible for determining all customer requirements, whether specified, not stated but necessary, or statutory and regulatory.

7.2.2 Review of Requirements Related to the Product Kalman Manufacturing reviews the requirements related to the product prior to the Company’s commitment to supply a product to the customer (e.g. submission of tenders,

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acceptance of contracts or orders, acceptance of changes to contracts or orders) and ensures:

product requirements are defined contract or order requirements differing from those previously expressed are

resolved the organization has the ability to meet the defined requirements

The review results and actions arising from the review are recorded and maintained. The Sales and Quality Departments are responsible for the review and control the records. Where the customer provides no documented statement of requirement, the customer requirements are confirmed by the Company before acceptance. Where product requirements are changed, the Sales and Quality Departments ensure relevant documents are amended and relevant personnel are made aware of the changed requirements.

7.2.3 Customer Communication Kalman Manufacturing determines and implements effective arrangements for communicating with customers in relation to:

product information enquiries, contracts or order handling, including amendments customer feedback, including customer complaints

7.3 Design and Development Kalman Manufacturing, in the development of its quality management system, has excluded the requirements of ISO 9001:2008 sub-clause 7.3 Design and Development. The Company considers customer specifications and design as a customer supplied product and has no authority or accountability for the design of its customers’ products. Therefore, the Company controls this according to ISO 9001:2008 sub-clause 7.5.4 Customer Property.

7.4 Purchasing

7.4.1 Purchasing Process Kalman Manufacturing ensures purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product is dependent upon the effect of the purchased product on subsequent product realization or the final product. The Company evaluates and selects suppliers based on their ability to supply product in accordance with the Company’s requirements. Criteria for selection, evaluation and re-

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evaluation is established. Records of the evaluation results and any necessary actions arising from the evaluation are controlled. The Purchasing/Sales and Customer Service Departments are responsible for controlling the purchasing process and for maintaining appropriate records. A documented procedure (OP00007) has been established for purchasing.

7.4.2 Purchasing Information Purchasing information describes the product to be purchased, including where appropriate:

requirements for approval of product, procedures, processes and equipment requirements for qualification of personnel quality management system requirements

The Company ensures the adequacy of specified purchase requirements prior to communication to the supplier.

7.4.3 Verification of Purchased Product Kalman Manufacturing establishes and implements the inspection or other activities necessary to ensure purchased product meets specified purchase requirements. A documented procedure (OP00008) has been established for receiving purchased product. When the Company or its customer intends to perform verification at the supplier’s premises, the Company states the intended verification arrangements and method of product release in the purchasing information.

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision Kalman Manufacturing plans and carries out production and service provisions under controlled conditions. Controlled conditions include, as applicable:

the availability of information that describes the characteristics of the product the availability of work instructions, as necessary the use of suitable equipment the availability and use of monitoring and measuring devices the implementation of monitoring and measurement the implementation of release, delivery and post-delivery activities

The Production Department, along with the Customer Service Department, is responsible for controlling all phases of product and service provision and for maintaining appropriate records. A documented procedure (OP00009) has been established.

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7.5.2 Validation of Processes for Production and Service Provision Kalman Manufacturing validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. (Ref. OP00009) Validation demonstrates the ability of these processes to achieve planned results. The Company establishes arrangements for these processes including, as applicable:

defined criteria for review and approval of the processes approval of equipment and qualification of personnel use of specific methods and procedures requirements for records revalidation

7.5.3 Identification and Traceability Where appropriate, Kalman Manufacturing identifies the product by suitable means throughout product realization. The Company identifies the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the Production Department controls and records the unique identification of the product.

7.5.4 Customer Property Kalman Manufacturing exercises care with customer property while it is under the control of or used by the organization. The Company identifies, verifies, protects and safeguards customer property or data provided for use or incorporation into a product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records are maintained. The Production and Customer Service Departments are responsible for controlling and recording customer property. The Sales Department and the Company President are responsible for all communication with the customer regarding their property.

7.5.5 Preservation of Product The Production Department, Shipping Department, and Assembly Department are responsible for preserving the conformity of product during internal processing and delivery to the intended destination. As applicable, this preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. A documented procedure (OP00010) has been established for the handling, storage, packaging and delivery of products.

7.6 Control of Monitoring and Measuring Equipment

Kalman Manufacturing determines the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of product conformity

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to determined requirements. The Company establishes processes to ensure monitoring and measurement can be and are carried out in a manner consistent with the monitoring and measurement requirements. The Quality and Production Departments are responsible for all aspects related to the system of controlling monitoring and measurement. Where necessary to ensure valid results, measuring equipment is:

calibrated, verified or both at specified intervals against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded

adjusted or re-adjusted as necessary identified to enable the calibration status to be determined safeguarded from adjustments that would invalidate the measurement result protected from damage and deterioration during handling, maintenance and

storage A documented procedure (OP00011) has been developed for the calibration of monitoring and measuring equipment used at Kalman Manufacturing’s facilities. In addition, the Company assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. The Company takes appropriate action with the equipment and any product affected. Records of the results of calibration and verification are to be maintained. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed. This is undertaken prior to initial use and reconfirmed as necessary.

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8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General

Kalman Manufacturing plans and implements the monitoring, measurement, analysis and improvement processes needed:

to demonstrate product conformity to ensure conformity of the quality management system to continually improve the effectiveness of the quality management system

This includes determination of applicable methods, including statistical techniques, and the extent of their use. The Quality Department is responsible for systems related to monitoring, measurement, analysis and improvement. (Ref. OP00012).

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction As one of the measurements of the quality management system performance, Kalman Manufacturing monitors information relating to customer perception regarding whether customer requirements have been met. The methods for obtaining and using this information are determined by the Sales/Purchasing and Customer Service Departments.

8.2.2 Internal Audit Kalman Manufacturing conducts internal audits at planned intervals to determine whether the quality management system:

conforms to the planned arrangements, to the requirements of ISO 9001:2008 and to the quality management system requirements established by the organization

is effectively implemented and maintained An audit program has been planned, taking into consideration the status 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. The selection of auditors and conduct of audits ensures 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 maintaining records, are defined in a documented procedure (OP00013). The Quality Department is responsible to oversee the internal auditing system and for controlling appropriate records. Management responsible for the area being audited ensures any necessary corrections or corrective actions are taken to eliminate detected nonconformities and their causes are

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taken without undue delay. Follow-up activities include the verification of the corrective action taken and the reporting of verification results.

8.2.3 Monitoring and Measurement of Processes The Quality and Production Departments are responsible for the monitoring of given processes. A documented procedure (OP00014) has been established. Kalman Manufacturing applies suitable methods for monitoring and measurement of the quality management system processes, where applicable. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, corrective action is taken by the appropriate personnel to ensure product conformity.

8.2.4 Monitoring and Measurement of Product Kalman Manufacturing monitors and measures the characteristics of product to verify product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria is maintained. Records indicate the person(s) authorizing release of product. Product release and service delivery do not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

8.3 Control of Nonconforming Product

The Quality Department is responsible for storing nonconforming material in a safe and separate location to prevent unintentional usage. Kalman Manufacturing ensures product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in a documented procedure (OP00015). The Company deals with nonconforming product in one or more of the following ways:

by taking action to eliminate the detected nonconformity by authorizing its use, release or acceptance under concession by a relevant

authority and, where applicable, by the customer by taking action to preclude its original intended use or application

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are controlled by the Quality Department. When nonconforming product is corrected, it is subject to re-verification to demonstrate conformity to the requirements.

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When nonconforming product is detected after delivery or use has started, the Company takes action appropriate to the effects, or potential effects, of the nonconformity.

8.4 Analysis of Data Kalman Manufacturing determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where improvement of its effectiveness can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources. A documented procedure (OP00016) has been established. The analysis of data provides information relating to:

customer satisfaction conformity to product requirements characteristics and trends of processes and products including opportunities

for preventive action suppliers

The Quality and Production Departments are responsible for determining the data requirements and for coordinating with other departments to collect and subsequently analyze the data in order to make improvements.

8.5 Improvement

8.5.1 Continual Improvement Kalman Manufacturing continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. A documented procedure (OP00017) has been established.

8.5.2 Corrective Action Kalman Manufacturing takes action to eliminate the cause of nonconformities in order to prevent their recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered. A documented procedure (OP00018) has been established that defines requirements for:

reviewing nonconformities (including customer complaints) determining the causes of nonconformities evaluating the need for action to ensure nonconformities do not recur determining and implementing action needed recording and maintaining records of the results of action taken reviewing the effectiveness of the corrective action taken

The Quality Department is responsible for controlling the procedure and the associated records.

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8.5.3 Preventive Action The Company determines necessary actions to eliminate the causes of potential nonconformities. Preventive actions are appropriate to the effects of the potential problems. A documented procedure (OP00018) has been established to define requirements for:

determining potential nonconformities and their causes evaluating the need for action to prevent occurrence of nonconformities determining and implementing action needed recording and maintaining the results of action taken reviewing the effectiveness of the preventive action taken

The Quality Department is responsible for controlling the procedure and the associated records.

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9.0 STANDARD OPERATING PROCEDURES INDEX

KALMAN SOP# SUBJECT

OP00000 Quality Management System

OP00001 Document Control

OP00002 Control of Records

OP00003 Management Review

OP00004 Training

OP00005 Safety and Work Environment

OP00006 Sales Order Processing/ Contract Review

OP00007 Purchasing

OP00008 Verification of Purchased Product

OP00009 Production and Service Provision

OP00010 Handling, Storage, Packaging, Preservation and Delivery

OP00011 Control of Measurement Equipment

OP00012 Monitoring and Measurement

OP00013 Internal Audit

OP00014 Monitoring and Measurement of processes

OP00015 Control of Nonconforming Product

OP00016 Analysis of Data

OP00017 Continual Improvement

OP00018 Corrective and Preventive Action