Maloya Quality Manual

Quality Manual
Authorizing
• Reto Hug, President	• Marc Anderes, Quality Control Manager

Table of Contents
	Company Profile
1.0	Introduction
1.1	Distribution Register, Revision History & Release
4.1	Management Responsibility
4.12	Organization
4.2	Quality Policy
4.1.3	Quality Objective
4.1.1	Quality System
4.3	Contract Review
4.4	Design Control
4.5	Document and Data Control
4.6	Purchasing
4.7	Control of Customer-Supplied Product
4.8	Product Identification and TRACEABILITY
4.9	Process Control
4.10	Inspection and Testing
4.11	Control of Inspection, Measuring and Test Equipment
4.12	Inspection and Test Status
4.13	Control of Nonconforming Product
4.14	Corrective and Preventive Action
4.15	Handling, Packing, Storage, Preservation and Delivery
4.16	Quality Records
4.17	Internal Quality Audits
4.18	Training
4.19	Servicing
4.20	Statistical Techniques
	Master list of Quality System Procedures

Maloya Laser is a fabricating service company which employs advanced CO2 laser cutting machinery for close-tolerance fast-turnaround and cost effective, high quality components.

Maloya will provide cutomers with superior components by utilizing state-of-the-art laser cutting technology. Support customers by meeting tight delivery schedules and their cost requirements with prompt quotations, innovative and rapid response engineering, extensive stainless and carbon steel inventories (certified as required).

The Quality System described herein will enable management and employees to comply with the MALOYA LASER INC. company Quality Policy, and to realize its objectives. The Quality System will provide for an organized systematic approach to all activities affecting quality, including verification. It also assures that each activity has been satisfactorily performed and demonstrates that the desired quality has been achieved.

Our goal is to ensure that products are designed and manufactured to contract requirements including performance, function, delivery, and to realize the Quality System objectives. When there is conflict between the statement of Quality Policy, the Quality System described herein, or our Company Practices, you are requested to inform the Quality Management Representative. In cooperation with the appropriate Manager, the Quality System or company practice will be evaluated, upgraded accordingly and aligned with the Quality Policy. In the event of unresolved conflict. the President shall arbitrate to conclusion.

This Manual was prepared using the ISO 10013 Guidelines. It is to be reviewed at least once per annum at a Management Review meeting to ensure relevancy of the information herein. Changes are authorized by the Originator [Management Representative], and approved by the President, after obtaining input from Executive Management attesting to the usability of the manual. The President has the final Release Authority for the complete implementation of the Quality Manual in its original, or revised form.

Where used for external or contractual purposes, reference can be made to ISO 9001: 1994 References to existing terms, concepts, definitions, and standards are interpreted in ISO 8402. Auditing of our Quality System shall be based upon the Policies stated within this manual.

Current issues of this manual are maintained with holders of a "controlled" copy as listed on page 5. Each "controlled" copy is individually identified. Uncontrolled copies of this manual are available to all employees and customers. When requested, a current issue copy will be forwarded. This request should be addressed to Quality Management Representative, MALOYA LASER INC. 65A Mall Drive, Commack NY. 11725

The following persons (listed by Job Title) have received a "Controlled" copyt of this Quality Manual;
#1 President
#2 VP Sales & Marketing
#3 VP Operations
#4 VP Production
#5 Quality Control Manager

REVISION HISTORY

Date	Description	Author	Revision
01-07-97	Original Release	Frank Cardaroploi	00
04-05-00	First Release	Reto Hug	01

Release Authority
Approval		Signature: Reto Hug
Job Title: President.		Date: 4-5-2000

4.0 QUALITY SYSTEM REQUIREMENTS

It is our policy to ensure that Executive Management is ultimately responsible for establishing, documenting, and implementing the Quality System, and ensuring the availability of resources and personnel necessary to maintain the system and to complete all necessary tasks. Executive Management shall establish priorities, objectives, and policies to match the requirements of the markets and customers we serve.

We shall assure that specific responsibilities include but are not limited to formulating the Quality Policy, assigning responsibilities and authorities, conducting documented management reviews with minutes, and defining and documenting specific Quality responsibilities for all employees.

We shall assure the appointment of a Management Representative who will oversee conformance to the Quality System as it pertains to ISO 9002: 1994, and delineate the appropriate level of responsibility ensuring verification activities are defined.

The Organization Chart in Section 4.1 shows the Executive Management structure and interrelationships["Job Titles" of Executive Management].

We shall ensure that individuals within the operation and relative to their area of responsibility, initiate the necessary actions to prevent occurrences of nonconforming materials, processes and services.

Executive Management designates and controls the channels through which these tasks are accomplished. By these means, we will foster an environment of continuous improvement.

We shall ensure that verification activities are implemented that include inspecting, testing, and monitoring design and production processes and the audit of the Quality System.

The quality policy and objectives for, and commitments to quality are defined and documented in the Quality manual and supporting procedures. (See Master Procedure list page 29)

4.1.1 Quality Policy and objectives

4.1.1 Quality System

It is the policy of Maloya Laser, Inc. to supply its customers with defect-free parts. In order to achieve this result, we will use continuous improvement techniques to improve all processes in the company. Our abjective is to become the top supplier of parts in our marketplace. We will use quality systems, and encourage employee participation to insure that our processes adhere to the best systems in the world. We are committed to this policy and require all employees of Maloya Laser, Inc. to comply. Our commitment to this policy is embodied in our Quality Policy.

At MALOYA LASER INC. we are committed to "CUTTING EDGE QUALITY"

This Quality Policy was originated by the President of MALOYA LASER INC. and approved by Executive Management. The Policy has been explained to and discussed with all existing employees, and is part of the new employee orientation process. This policy is also posted in many observable areas throughout the company.

Our Quality Objective is to set a vision for our company, incorporating a Quality System that, together with training, teamwork, and communication, will bring a level of continuous improvement to the company which will allow us to be successful as we grow and learn.

There are several principles that we abide by to achieve this stated objective:

1	We will provide a company-wide initiative to continuously improve the quality of our products and services for our customers, and the quality-of-life for our employees.
2	We will break down the internal barriers that promote "politics", and stress "teamwork" as a replacement.
3	We will continuously improve our communications with our valued customers, employees, and our subcontractors.
4	We will recognize and reward our valued employees who demonstrate the willingness to bring the philosophy of continuous improvement into the workplace.
5	We will develop plans to provide for the resources and activities that satisfy the constantly changing needs of our customers.

This Quality Policy was originated by the President of MALOYA LASER INC. and approved by Executive Management. The Policy has been explained to and discussed with all existing employees, and is part of the new employee orientation process. This policy is also posted in many observable areas throughout the company.

4.2 QUALITY SYSTEM

4.2.1 GENERAL
The quality system documents and its supporting procedures are designed to ensure that it is easily understood, is effective and the products supplied conform to customer requirements.

Procedures are written to support the elements of the quality system contained within the manual. Controlled copies of all procedures are located in specific areas and in the procedures manual that is maintained by the quality control manager. In certain cases work instructions which detail how processes should be carried out are referenced within the procedures. Work instructions are also maintained in designated areas.

The President has ultimate responsibility to oversee quality plan preparation.

The VP Production pre-plans the sequence of steps to produce each job. His preliminary review is used to identify items which present challenges beyond the scope of normal daily activities. When unusual demands are identified, Maloya Laser Inc. seeks out a subcontractor able to meet those demands, or adds equipment and skills to its own shop. (see QP 6) Maloya will take responsibility for the quality of the product shipped.

4.3 CONTACT REVIEW

Prior to contract acceptance, is reviewed to ensure that;

a) the requirements are adequately defined and documented
b) where no written statement of requirements is available for an order received by verbal means, the President or Shop Foreman ensures that the requirements are agreed upon before acceptance
c) any differences between the contract requirements and those in tender are resolved
d) Maloya has the ability to meet the customer’s order requirements

4.3.3 AMENDMENT TO CONTACT
Maloya Laser Inc. has documented guidelines for amending contracts and communicating amendments to the functions concerned within the organization. (See QP 3)

4.3.4 RECORDS
Records are maintained by the office staff and located in the “jobs completed” file.

4.4 DESIGN CONTROL
MALOYA LASER INC. is not involved in Design, therefore our Quality System does not include requirements for this element.

4.5 DOCUMENT AND DATA CONTROL
MALOYA LASER INC. is not involved in Design, therefore our Quality System does not include requirements for this element.

4.5.1 GENERAL
Maloya Laser Inc. has documented procedures to control documents and data that relate to the Quality system (See QP 5)

Prior to their being issued, the President reviews and approves all documents and their amendments that are generated by the VP Manufacturing or the Production Manager at Maloya. A master list is kept with the most current revisions and locations of controlled documents. Customer furnished drawings are maintained in a file cabinet and identified with the electronic data file name. A master list of current revisions is maintained in the Maloya MIS Customer Router Module.

All documents found to be superseded or obsolete are labled as "superceded" and archived. Obsolete documents that are kept are identified as such to prevent inadvertent use (see QP 5)

4.5.3 DOCUMENT AND DATA CHANGES
Changes to documents and data are reviewed and approved by the President. Any copies of a controlled document that may be sent out of the company are stamped “UNCONTROLLED” by the office staff before distribution. These copies will not follow the revision procedure. (See QP 5) No, “UNCONTROLLED” documents are used in the production of parts.

4.6 PURCHASING
MALOYA LASER INC. is not involved in Design, therefore our Quality System does not include requirements for this element.

4.6.1 GENERAL
There are documented procedures to ensure that the product and services purchased from subcontractors or vendors conform to specified requirements.

4.6.2 EVALUATION OF SUBCONTRACTORS
Subcontractors are selected on their ability to meet quality requirements including delivery time and price. They are also selected on their past performance. Subcontractors are evaluated on Demonstated Capability. (See QP 6.0) Records of acceptable subcontractors are maintained by the Purchasing Agent.

4.6.3 PURCHASING DATA
In all purchase orders, the requirements of the product are clearly stated, this is usually attained by specifying type, class, or grade of the product required. This will include, where applicable, the quality system that applies and is reviewed as needed. The requirements for work subcontracted out are specified by providing a blueprint or hand sketch.

4.6.4 VERIFICATION OF PURCHASED PRODUCT

Where Maloya decides to verify purchased product at a subcontractor’s premises, checks are performed by source inspection or by subcontractor product certification of individual shipments. The purchasing agent specifies the verification requirements and documents the quality plan the subcontractors agrees to work by, when applicable. Where a quality plan does not exist for the subcontractor, receiving inspection procedures are followed. (QP 10.1)

4.6.4.2 CUSTOMER VERIFICATION OF SUBCONTRACTED PRODUCT
Currently and in the anticipated future this element is not required; however; if required a procedure will be developed.

4.7 CONTROL OF CUSTOMER SUPPLIED PRODUCT
Procedures are maintained and documented for the verification, storage and maintenance of customer supplied product that has been provided for incorporation into further processes. Lost, damaged, or otherwise unsuitable products are recorded and reported back to the customer. The Quality Control manager is responsible to control this system. (See QP 7)

4.8 PRODUCT IDENTIFICATION AND TRACEABILITY
Product identification and traceability are normally not required; however, when traceability is required the process sheet identifying the work processes is available and is maintained in the jobs completed file. (See QP 8) Packaged final product is not released from the production area until appropriate identification is attached.

The VP Manufacturing is responsible for identifying and planning the production process that directly affects quality. The process flow is controlled by a process sheet. The VP Manufacturing and Production Manager together will:

a) Identify how production is planned and controlled.
b) asssure the availability of trained personnel, appropriate Manufacturing resources, instructions (as needed), and suitable working environment.
c) assure production is conducted in compliance with applicable standards and with documented procedures.
d) Monitor the level of workmanship on parts being produced. e) Provide for maintenance and calibration of equipment to ensure continued process capability. f) Monitor and control process parameters and product characteristics. (See QP 9)

4.10 INSPECTION AND TESTING

Procedures exist to ensure that inspection and testing is carried out to verify product requirements are met. Incoming raw material and products are verified before being released for use or shipped to the customer. In process inspections are carried out by the employee working on the product. When the customer requests documentation, a final inspection is performed and dimensions tabulated before the product is shipped to the customer.

4.10.2 RECEIVING INSPECTION AND TESTING
Upon receipt of material or products (See QP 10.1), they are inspected to ensure that it meets the specified requirements. The inspection level, unless otherwise specified in the contract, is determined by the approved subcontractor list. (See QP 6.1) Products not conforming to requirements are segregated and held for dispositioning. (See QP 13)

4.10.3 IN-PROCESS INSPECTION AND TESTING
In-process work is continually inspected to ensure conformity to blueprint specifications or to the instructions of the Shop Foreman. Parts that are found to be out of tolerance are dispositioned, prior to being passed on to the next operations. (See QP 10.2)

All features are inspected as the part is being produced. When required by the customer, final inspection is carried out. Only after verification that the product conforms to all requirements and inspection results are documented, is the product authorized to be shipped. (See QP 10.3)

Rejected material is tagged and marked as such. Rejected material is repaired, reworked or released under proper authority from the customer. (See QP 13)

4.10.5 INSPECTION AND TEST RECORDS
Inspections records are maintained by the office staff and kept in the “jobs completed” file.

4.11 CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT
Inspections records are maintained by the office staff and kept in the “jobs completed” file.

4.11.1 GENERAL
Documented procedures exist to control, calibrate, and maintain inspection, measuring, and test equipment used by Maloya to demonstrate conformance of a product to the specified requirements.

Inspection, measuring, and test equipment is checked to prove that they are capable of verifying the acceptability of product, prior to release. Measuring equipment is rechecked at prescribed intervals. A log is maintained of all calibrated equipment. (See QP 11 )

Equipment found to be out of calibration is repaired, replaced, or otherwise disposed of.

All equipment used for measuring products is calibrated with traceability back to the National Institute of Standards and Technology (NIST).

4.12 INSPECTION AND TEST STATUS
All employees are responsible for ensuring the products conform to specifications before releasing them to the next process. This is done by signing off on the process sheet that the product conforms. (See QP 12) All products that are nonconforming are segregated. (See QP 13)

4.13 CONTROL OF NONCONFORMING PRODUCT

4.13.1 GENERAL
Procedures are maintained to ensure product that do not conform to specified requirements is prevented from inadvertent use. The Quality Control manager is responsible for nonconforming product. This includes identification, documentation, evaluation, and segregation of nonconforming product. (See QP 13)

Maloya will notify the customer of nonconforming products. The customer will determine if the product is acceptable or if Maloya must repair, rework, or scrap the product. When appropriate, the President and Shop Foreman will review, discuss and document corrective and preventive action to avoid the nonconformity in the future. (See QP 14)

Nonconforming product is not shipped unless the customer is notified and has authorized it to be released. Documentation of the nonconformity will be kept in the “jobs completed” file.

4.14 CORRECTIVE AND PREVENTIVE ACTION
All employees are responsible for ensuring the products conform to specifications before releasing them to the next process. This is done by signing off on the process sheet that the product conforms. (See QP 12) All products that are nonconforming are segregated. (See QP 13)

4.14.1 GENERAL
Procedures are documented for corrective and preventive action. These are used to eliminate the causes of actual nonconformance and to prevent nonconformances from occurring. Trends or patterns of problems will be discussed during the Management review.

4.14.2 CORRECTIVE ACTION
Customer complaints of end product nonconformances are handled by the President or VP Production. Internal nonconformances are handled by the Quality Control manager. The causes of the nonconformances are investigated and corrective action taken, documented, and evaluated for effectiveness.

4.14.3 PREVENTIVE ACTION
Maloya uses resources such as audit results of CAR/PAR’s, quality records and customer complaints to detect, analyze and eliminate potential causes of nonconformances. The steps necessary to handle preventive actions are determined by management and action initiated. All employees are encouraged to notify the Quality Control Manager of potential problems.

Maloya has procedures for handling, storage, packaging, preservation and delivery that are structured and controlled to prevent the damage or deterioration of products. Personnel are trained to handle products to prevent damage or deterioration. (See QP 15)

Finished products are stored to prevent damage and degeneration. Prior to shipping, stocked items are checked to ensure that no deterioration or damage has occurred.

Quality records are identified, collected and filed in the main office. They can be traced back to a specific product and are stored to facilitate effective retrieval and to prevent damage or deterioration. The retention period for individual Quality records is defined. (See QP 16), unless otherwise specified in the contract. Documents that define the quality system include; the Quality Manual, Quality Procedures and record of internal audits and are controlled by the President.. Quality records can be retrieved within four working days. (See QP 16)

Maloya performs management reviews on an annual basis.

Maloya Laser Inc. has established, documented and continues to maintain an audit program which objectively evaluates their quality system. Internal audits evaluate procedures and quality records. These audits are carried out by appointed personnel who are independent from the area that is being audited. Audits are carried out on a schedule that is established by the President. (See QP 17)

The results of the audits are recorded and brought to the attention of the personnel in the area that was audited. Audit results are reviewed and corrective action is initiated.

Follow up activities take place to ensure that the corrective action taken was implemented and is effective.

The President is responsible for establishing the training needs for the company and confirming the training level of all employees. Education, skill, or experience requirements are maintained, as well as the current status of each employee. All new employees are placed on an in-house training schedule to ensure that the proper level of training is achieved and quality is not affected. Employees are also trained in the quality procedures that pertain to their area. (See QP 18)

Records of the skill level and education of all employees are maintained.

4.19 SERVICING
Present and future plans do not require this standard.

4.20 STATISTICAL TECHNIQUES
Current business does not require the use of statistical techniques.