Quality Policy Manual

 

Matis Inc.

 

 

Table of Contents

Information Page

Revision History

Distribution List

Introduction

Quality Policy and Objectives

Organization

IS0 9000-Based Requirements

4.1 Management Responsibility

4.2 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, Storage, Packaging, Preservation, and Delivery

4.16 Control of Quality Records

4.17 Internal Quality Audits

4.18 Training

4.19 Servicing

4.20 Statistical Techniques

Glossary

Bibliography

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INFORMATION PAGE

Document Title: Quality Policy Manual

Document Number: QPM – 001

Issuer: Management Rep.

Approved By:

Revision: 1

Revision Date: Friday, April 23, 1999

Organization: Matis Inc.

Organization Abbreviation: None

 

SIC Code: 5048

Address: 10235 Southwest Highway

Chicago Ridge, IL 60415

REVISION HISTORY

Revision Description Revision History

1 Saved as draft copy. 4/13/99

2 Initial draft under MS Word 97 4/25/99

3 Final draft 5/15/99

DISTRIBUTION LIST

Management Representative JAY

INTRODUCTION

Matis Inc. has instituted a quality management system.

This manual describes its policies and company-wide control system. This quality management system addresses the requirements of the ISO (International Organization for Standardization) Quality Standards as defined in ISO 9001-1994 and ANSI/ASQC Q9001-1994.

 

ORGANIZATION OVERVIEW

The name of this organization is Matis Inc. It is located at:

10235 Southwest Highway

Chicago Ridge, IL 60415

The company distributes products to the tool, die, mold, and fixture industry.

Matis Inc. was founded in 1955. Annual sales for the company are in excess of $5 Million, and the company employs approximately 19 people.

The company is classified under SIC Code 5048.

MISSION

The mission of Matis Inc. is to provide products and application support that will meet or exceed our customers requirements.

QUALITY POLICY

Policy

The management of Matis Inc. is committed to quality and the policy for quality. This commitment is reflected in the company's mission statement and in the following objectives for quality.

Objectives

  1. Maintain a formal quality system meeting all ISO 9002 standards.
  2. Communicate our quality policies and objectives to all employees.
  3. Provide education and training to all employees to support their health, welfare, and safety.
  4. Develop relationships with our suppliers that emphasize continuous improvement in product quality, service, and support.
  5. Create statistical techniques to measure the performance of Matis and suppliers to Matis.

 

Organization Information:

Matis operates in its production facility at one location in

10235 Southwest Highway

Chicago Ridge, IL 60415

 

The senior executive responsible for operation is the President.

Matis Inc. maintains a written organization chart designating positions of company officers, managers, and employees.

4.1 MANAGEMENT RESPONSIBILITY

Executive management of Matis Inc. is responsible for establishing policy, objectives and commitment to quality.

4.1.2.1 The policy will be implemented and maintained company wide through delegation of authority and responsibility to an appointed management representative and documented training.

4.1.2.2 Quality objectives are documented in the quality policy manual (QPM-001) these objectives are reviewed at management review meetings when appropriate.

4.1.2.3 In-house resource verification requirements are identified and documented at the quality planning stage. (Ref. QD-002)

4.1.2.4 Individual responsibilities, authorities, and interrelation of personnel will be documented using job descriptions(QD-024 series), an organizational chart(QD-023), and a training matrix.(QD-021)

        1. Management review meetings are held at minimum on a quarterly basis. The President is responsible to create or modify an existing agenda (QD-018) for management review meetings. Required attendees for management review meetings are: President, controller, sales manager, management representative or at least three out of the four. Other personnel may attend by appointment of the President.

Objectives for management review meetings are to maintain a formal quality

system, communicate quality policy and objectives to all employees, provide for

employee training and resource issues, and review statistical techniques used to

measure the performance of Matis Incorporated and our suppliers.

4.1.2.6 Quality records of Management responsibility are maintained as specified. (Ref. 4.1.4.2)

      1. Responsibility
      2. President or appointed personnel

      3. References
        1. ANSI / ASQC Q9002-1994, 4.1
        2. Corporate Quality Policy Manual, 4.16
      1. Procedures
        1. 4.1 (QPM – 001)
        2. Management Review Agenda (QD – 018)

4.2 QUALITY SYSTEM

Matis Inc. maintains a formal quality system to ensure that products conform to specified requirements. The quality system is designed to meet ANSI/ASQC Q9002-1994.

4.2.2 Key System Components

4.2.2.1 The quality system is documented in the Matis quality policy manual.

4.2.2.2 The quality system functions and intentions are understood at all levels of the organization through documented training.

4.2.2.3 The procedures called out in the quality policy manual meet the ASQ/ANSI 9000 standard.

4.2.2.4 Quality planning activities define and document how quality requirements will be met when entering customer requirements for these activities into the P21 computer system. This is done for each order entered. Anyone entering an order into the computer system becomes a quality planner.

        1. Effective implementation of the quality system is supported and monitored by management through delegation of authority to a management representative and management review meetings.
      1. Responsibility
      2. Management Representative or appointed personnel

      3. References
        1. ANSI / ASQC Q9002 – 1994, 4.2
      1. Procedures
        1. 4.2 (QPM – 001)

4.3 Contract Review4.3.1 Policy

Matis Inc. ensures that all requirements received from the customer are fully understood and that current capability exists to meet all aspects of the customer requirements prior to the acceptance of the contract.

4.3.2 Key System Components

        1. The scope of this policy includes all contracts received for the purchase of product and/or services for stock or customer purposes.
        2. At Matis quality planning is responsible to document customer requirements into the computer system. If the product is a stock item, customer requirements can be documented by anyone. If the products are non stock items, they are to be reviewed by the president or appropriate personal. The requirements are to be validated against our and /or the suppliers ability to meet the requirements requested. Receipt of an order will be documentation that this occurred . Upon receipt of an order quality planning will verify the order and /or purchase order for consistency. This will be documented by way of generating a ship order form (QD-009) or a purchase order (for drop ship orders). All verbal orders are to be treated as specified. (Ref. 4.3.5.1) All prices quoted for stock items are set prices. Non stock items are to be reviewed by the president or appropriate personal before being quoted.
        3. Amendments to contracts are treated as specified. (Ref. 4.3.5.1) The amendment will be attached to the original when possible. Quality planning will notify all appropriate personnel when an amendment cannot be accommodated.
        4. References
          1. ANSI / ASQC Q9002 – 1994, 4.3
          2. Corporate Quality Policy Manual, 4.16
        5. Procedures
          1. 4.3 (QPM – 001)
          2. New product approval form (QD – 003)
    1. Design Control
      1. Policy

Matis Inc. does not perform its own design functions.

Thus, this section and its requirements are not applicable at this time.

4.5 Document and Data Control4.5.1 Policy

Matis Inc. controls all quality related documents and data. Control extends from the initial concept through review, approval, issuance and obsolescence.

4.5.2 Key System Components

        1. The scope of this policy includes those documents and/or computer records pertinent to purchasing, work execution, quality standards, inspection of materials, and the supplier's internal documented procedures. These may include

M.S.D.S. , blue prints, catalogs and other documents supplied to Matis Inc..

4.5.2.2 All quality documents at Matis will be reviewed and approved by the management review meetings, document originators, or the president. To change documents, the completed approval change request form (QD-005) will be obtained by the management representative. If approved, by management review or the president, it is then documented in the document master list (QD-007) which coincides with the previous same document.

4.5.2.3 All approved documents will contain at a minimum an incremental revision number greater than the previous and the date of the revision approval, Documents are available at all locations where operations effecting the quality system are performed.

4.5.2.4 The master list will be updated by the management representative as needed and the obsolete document will be archived in a file marked "obsolete documents". The management representative will distribute the approved documents where applicable and collect all same obsolete documents and destroy them. All personnel affected by the change will be notified by the management representative.

        1. Quality records of document and data control are maintained by the management

rep. through a protected software system and a master list.

4.5.3 Responsibility

Management review committee or appointed personnel

4.5.4 References4.5.4.1 ANSI / ASQC Q9002-1994, 4.54.5.4.2 Corporate Quality Policy Manual , 4.16

4.5.4.3 Corporate Quality Policy Manual , 4.1

      1. Procedures
        1. 4.5 (QPM – 001)

4.6 Purchasing4.6.1 Policy

Matis Inc. ensures that products and services obtained from sub-contractors conform to specified requirements.

4.6.2 Key System Components

        1. The scope of this policy includes all activities involved in purchasing products and services from suppliers that affect quality.
        2. Suppliers who affect the quality of product and service will be approved and qualified by purchasing personnel using the supplier approval checklist (QD-008). These checklists will be kept at the desk of the purchasing manger in a designated file. As of March 1999, all current suppliers are approved. New suppliers will be approved by appropriate personnel and a supplier approval checklist will be filled out . Removal of suppliers is at the sole discretion of Management review at Matis. Management review will use performance statistics generated from the corrective/preventive action forms, supplier reputation and any other pertinent information about the supplier as means for removal. One time suppliers may be used without approval to fill a customers requirements.
        3. Purchasers have the authority to purchase at Matis. When products or services are purchased the requirements are to be clearly called out when entered into the computer system along with any special requirements. At a minimum they will include a sufficient product description as to identify the product for check in where applicable, product quantity, product cost, unit of measure, purchase order number, purchase order date, supplied "To:", "Ship To:", and internal information where applicable. Purchasers may approve their own purchase orders up to the amount needed to satisfy the stock requirements or customers order. Anyone at Matis has the right to purchase product to fill a customer need, a stock requirement, or a requisition.
          1. Purchasers are responsible to document on purchase orders when Matis proposes to verify product at a subcontractor's premises. The purchaser must specify verification arrangements and the method of product release in the purchasing documents.
          2. Purchasers will document on the purchase order when a customer requests the verification of product to the specified requirements at the Matis facility or at a subcontractors facility. This verification will not be used by Matis as evidence of effective quality control by the subcontractor nor shall it absolve Matis of the responsibility to provide acceptable product or subsequent rejection by the customer.
        4. Quality records of Purchasing are maintained. (Ref. 4.6.4.2)

4.6.3 Responsibility

Purchasing Manager or appointed personnel

4.6.4 References

4.6.4.1 ANSI / ASQC Q9002-1994, 4.6

        1. Corporate Quality Policy Manual, 4.16
      1. Procedures
        1. 4.6 (QPM – 001)
        2. Supplier Approval Checklist (QD – 006)

4.7 Control of Customer Supplied Product

4.7.1 Policy

Matis inc. ensures that products furnished by customers are verified, stored and maintained.

4.7.2 Key System Components

4.7.2.1 All product supplied by customers will be verified against the packing slip and marked as such with a blue tag or blue mark upon receipt through shipping by inspectors. Product will be segregated and stored as to maintain it's integrity until it is processed and returned to the customer. If the product is found to be unsuitable, lost, or damaged, warehouse personnel will document this on the corrective/preventive form and communicate this to quality planning. Quality planning will notify the customer as to the disposition of product. Quality planning will process the quote/repair as specified. (Ref. 4.7.4.3)

        1. Quality records of Control of customer supplied product are maintained. (Ref. 4.7.4.2)

4.7.3 Responsibility

Warehouse manager or appointed personnel

4.7.4 References

4.7.4.1 ANSI / ASQC Q9002-1994, 4.7

4.7.4.2 Corporate Quality Policy Manual, 4.16

4.7.4.3 Corporate Quality Policy Manual, 4.3

      1. Procedures
        1. 4.7 (QPM – 001)

4.8 Product Identification and Traceability4.8.1 Policy

Matis Inc. ensures that products maintain identification and traceability asrequired by customer contract

4.8.2 Key System Components

4.8.2.1 All product maintained at Matis will be identified from receipt through shipping. All product will be either identified with a supplier label, a Matis bar code, or will have an identification bin. At a minimum, the identification will include the part number and/or description.

4.8.2.2 All product can be traced back to the inspection records through the use of the shipper number, invoice number, or ship date. Products that have been in stock prior to Jan. 1999 and products that were rejects or returns are exempt to traceability, however they will be inspected before shipping to a customer. If the customer requires additional traceability requirements, these requirements will be addressed during quality planning and documented on the ship order. (Ref. 4.8.4.2)

4.8.2.3 Quality records of product identification are maintained (4.8.4.3).

      1. Responsibility

Warehouse Manager or appointed personnel

4.8.4 References

4.8.4.1 ANSI / ASQC Q9002-1994, 4.8

4.8.4.2 Corporate Quality Policy Manual, 4.16

4.8.4.3 Corporate Quality Policy Manual, 4.2

    1. Process Control

4.9.1 Policy

Matis inc. identifies, plans, and controls production, installation and servicing processes which directly affect quality.

4.9.2 Key System Components

4.9.2.1 The scope of this policy includes all production, distribution and support processes.

4.9.2.2 The management representative at Matis is responsible to create and provide all documented work instructions to personnel who affect quality. These instructions can be in any form of media appropriate to complete the job. These instructions will be in accordance with the skill and education levels of the employees.

        1. At the quality planning stage all processes needed to distribute or produce the product or service will be documented. (Ref. QD-009) (Ref. 4.9.4.3)
          1. The warehouse manager will ensure that the work instructions and procedures are followed.
          2. Inspections at Matis verify that the specifications and requirements are being met. (Ref. 4.9.4.4)
          3. If a customer required first part approval of a product, quality planning would document this as specified. (Ref. 4.9.4.5)
          4. A comprehensive maintenance system will ensure our machines are working properly and are in compliance with applicable government safety and environmental regulations. The maintenance will be documented onto maintenance records for each machine by qualified personnel.
          5. The management representative will provide and maintain a safety program to ensure suitable working conditions.

4.9.2.4 Records are maintained for qualified processes, equipment, personnel and include references to the requirements for such qualifications. (Ref. 4.9.4.2)

      1. Responsibility

Warehouse manager / Management rep.

4.9.4 References

4.9.4.1 ANSI / ASQC Q9002-1994, 4.9

4.9.4.2 Corporate Quality Policy Manual , 4.16

4.9.4.3 Corporate Quality Policy Manual , 4.2

4.9.4.4 Corporate Quality Policy Manual , 4.10

4.9.4.5 Corporate Quality Policy Manual , 4.3

4.9.5 Procedures

4.9.5.1 4.9 (QPM-001)

4.10 Inspection and Testing

4.10.1 Policy

Matis Inc. maintains documented procedures for inspection and testing to verify that specified requirements for products are met.

      1. Key System Components
        1. The scope of this policy includes all inspection and testing activities.
        2. All inspection and test criteria required will be documented during the quality planning stage. (Ref. 4.10.4.4)
        1. All product will be inspected upon receipt through shipping. This in-coming inspection will include at a minimum quantity verification, description verification,( per print verification where applicable), and visual check for damaged product. 100% of incoming product is inspected. If products are not broken and appear to be correct shape, size, and color they are then deemed ok. Verification of this inspection will be documented on the packing slip. The in-process inspection will occur when product is pulled from stock or manufactured in accordance to the ship order. This inspection will include at a minimum quantity count, description verification, verification of previous inspections. The inspection will be documented on the ship order by personnel conducting the in-process inspection initialing the "checked by" space, and initialing individually any other critical inspections documented by quality planning. Personnel packaging the product will conduct final inspections. Final inspection will include at a minimum quantity verification, description verification,(per print verification where applicable), and previous inspections verification. This inspection will be documented on the ship order by personnel conducting the final inspection initialing the "packed by" space. (Note: The in-process and final inspections should not be performed by the same personnel if possible.)
        2. All product found to be nonconforming will be identified and handled as specified. (Ref. 4.10.4.2)
        3. Positive recall will only be used when the customer requires it. This will be documented at the quality planning stage.
        4. No product will be dispatched until all inspections and tests are carried out and documented in conformance with the quality plan.
        5. Quality records are maintained on all inspections and tests (4.10.4.3).

4.10.3 Responsibility

Quality Manager or appointed personnel

4.10.4 References

4.10.4.1 ANSI / ASQC Q9002-1994, 4.10

4.10.4.2 Corporate Quality Policy Manual , 4.13

4.10.4.3 Corporate Quality Policy Manual , 4.16

4.10.4.4 Corporate Quality Policy Manual , 4.2

4.10.5 Procedures

4.10.5.1 4.10 (QPM-001)

4.11 Control of Inspection, Measuring and Test Equipment

4.11.1 Policy

Matis Inc. ensures that inspection, measuring and test equipment is controlled, calibrated and maintained. This equipment is consistent with the required measurement capability.

4.11.2 Key System Components

        1. The scope of this policy includes all inspection, measuring, test equipment and software used to demonstrate the conformance of product to the specified requirements.
        2. Inspection, measuring, test equipment, hardware and software which affect quality is identified in the gauge log, calibrated and adjusted at 1 year intervals or prior to use against certified equipment traceable to nationally recognized standards, in a suitable environment, and the results recorded. Gauges are to be stored in their case holders and handled with care in the area where they are used. Only employees that have been trained to use gauges should use them. Gauges are identified according to serial number and or model number or type of gauge.
        3. Test and inspection equipment will be used to measure 10 times the specified accuracy of the gauge. (ie: calipers are accurate to + - .OO1, so we measure to + - .OlO.) Tape measures will be used to measure within l/32 of an inch. Gauges are to be calibrated using gauge blocks which have been certified according to nationally recognized standards. Tape measures will be calibrated using a steel rule which has been certified according to nationally recognized standards.
        4. Equipment which has been calibrated and is in good standing will have a green calibration sticker (QD-016) attached to it and the gage entered onto the gauge log. Equipment which is found to be out of calibration will have a red sticker attached to it (QD-017) and segregated for evaluation by the management representative. If the equipment is deemed fixable it will be fixed, calibrated, a green calibration sticker attached to it, and reentered into use. If the gauge is not repairable it will be scrapped and replaced by a new piece of equipment. When equipment is found out of calibration, validity of prior inspections will be assessed using the data from corrective/preventive requests. Any product which was measured with a gauge which was found out of calibration and is still at Matis Inc. will be quarantined and re-inspected with gauging which is in good standing.
        5. If equipment is found to be out of calibration, validity of prior inspections is assessed by the warehouse manager using completed corrective/preventive requests.
        6. If contractually required, measurement system design data is made available to our customers or their representatives for verification of functional adequacy. This will be documented at the quality planning stage.
        7. Quality records of calibrations and adjustments are maintained. (Ref. 4.11.4.2)
      1. Responsibility

Management representative or appointed personnel

4.11.4 References

4.11.4.1 ANSI / ASQC Q9002-1994, 4.11

4.11.4.2 Corporate Quality Policy Manual , 4.16

4.11.5 Procedures

4.11.5.1 4.11 (QPM-001)

4.12 Inspection and Test Status

4.12.1 Policy

Matis Inc. ensures that products maintain the identification of inspection and test status.

4.12.2 Key System Components

4.12.2.1 All products maintained at Matis will be identified to its inspection and test status. All product, after incoming inspection, will be identified with a blue mark or blue tag to indicate the conformance of the product. If product is found to be non-conforming it will be put into the nonconforming product area and labeled with a red tag.

4.12.2.2 The inspection status of product, after in-process inspection and final inspection, will be identified on the ship order. The inspector will be required to initial each inspection step to indicate conformance.

4.12.3 Responsibility

Warehouse Manager

4.12.4 References

4.12.4.1 ANSI / ASQC Q9002-1994, 4.12

4.12.5 Procedures

4.12.5.1 4.12 (QPM-001)

    1. Control of Nonconforming Product
      1. PolicyMatis Inc. ensures that product that does not conform to specified requirements is prevented from unintended use. Control will provide for identification, documentation, evaluation, segregation (when practical), disposition and notification of areas affected.

4.13.2 Key System Components

4.13.2.1 All product found to be non-conforming with specified requirements by inspection, testing or other means will have a corrective/preventive request started, a red tag filled out and attached to the product. The product is to be placed in the designated area for non-conforming product. The warehouse manager will evaluate the product and when deemed necessary the product will be reworked to meet the specified requirements called out in quality planning, accepted with or without repair by concession from the customer, regraded for alternative applications, rejected or scrapped. The disposition of these products will be later recorded on the corrective/preventive request form. When product is reworked it shall be re inspected in accordance with the quality planning requirements which are the original requirements specified when the product was ordered. The manager will take action to notify all areas affected by the non-conformance.

        1. Quality records of nonconforming product activity are maintained. (Ref. 4.13.4.2).
        2. Responsibility
          1. Warehouse manager or appointed personnel
        3. References
          1. ANSI / ASQC Q9002 – 1994, 4.13
          2. Corporate Quality Policy Manual, 4.16
        4. Procedures
          1. 4.13 (QPM - 001)

4.14 Corrective and Preventive Action

4.14.1 Policy

Matis Inc. utilizes documented procedures for corrective and preventative action to eliminate the causes of actual or potential nonconformities.

      1. Key System Components
        1. The scope of this policy includes all actions taken to reduce non-conformance.
        2. Matis uses a corrective/preventive action request to document internal , vendor and customer nonconformances and the actions taken to reduce actual and prevent potential nonconformances. The request will include at a minimum, the description of the non-conformance, the root cause, investigation results, actions taken to correct the non-conformance, prevent recurrence of the same or potential non-conformance and audit information. The corrective and preventive actions will be reviewed at management review meetings.
          1. Matis utilizes the information from the request forms to create the statistical charts needed for management review to plan and prioritize our preventive actions and process improvements. All request forms will be logged by Matis using codes to define the nonconformances. Prior to management review meetings, the management rep. will prioritize the noncomformances that will be discussed during management review. These forms will be reviewed and prioritized during management review meetings to determine actions to be taken. The management rep. will review open corrective/preventive request to insure follow up.
        3. Quality records of corrective and preventive actions are maintained (4.14.4.2).
      2. Responsibility
      3. Management representative or appointed personnel

      4. References
        1. ANSI / ASQC Q9002 – 1994, 4.14
        2. Corporate Quality Policy Manual, 4.16
      5. Procedures
        1. 4.14 (QPM – 001)
  1. Handling, Storage, Packaging, Preservation, and Delivery
    1. Policy
    2. Matis Inc. ensures that products are controlled through handling, storage, packaging, preservation and delivery in such a manner that product integrity is maintained.

    3. Key System Components
      1. Matis ensures product is handled safely through delivery by utilizing qualified personnel. (Ref. 4.15.4.2)
      2. All special handling requirements will be called out at the quality planning stage. (Ref. 4.15.4.3) Special handling or packing requirements will be documented on work orders.
      3. A storage area with environmental controls, bin locations, and designated areas for product is maintained. The area is cleaned and kept orderly by warehouse personnel to preserve and segregate product until it is dispatched.
        1. Product is received into stock by warehouse personnel checking it in. The check in of product includes an in-coming inspection, verification of packing slip against our purchase order and the quantities updated in the computer system. Product is dispatched from stock only when a ship order is received by warehouse personnel calling for that specific product.
      4. Stock is periodically assessed to detect deterioration. This is done during the picking of orders and while putting stock on the shelf. All product that is found to be deteriorating beyond useable or sellable means will be treated as specified. (Ref. 4.15.4.4) Internal audits will be used to monitor this process.
      5. Packing, packaging, and markings required by the customer are documented at the quality planning stage. (Ref. 4.15.4.3) This information is then transferred to the work order shipping paper.
      6. Matis will use approved carriers only when a customer requires us to deliver or contract a carrier for shipment. Matis insures that product will maintain its quality throughout all stages of delivery by properly packing products in accordance with the delivery method.
    4. Responsibility
    5. Purchasing Manager

    6. References
      1. ANSI / ASQC Q9002 – 1994, 4.15
      2. Corporate Quality Policy Manual, 4.18
      3. Corporate Quality Policy Manual, 4.3
      4. Corporate Quality Policy Manual, 4.13
    7. Procedures
      1. (QPM – 001)

4.16 Control of Quality Records

4.16.1 Policy

Matis Inc. maintains quality records to provide evidence that the quality system elements have been effectively implemented.

4.16.2 Key System Components

4.16.2.1 Quality records are identified in the document master list. Each catalogue or document at a minimum will be accompanied by or include a document number, revision level, and date of approval. Quality documents will be issued, indexed, stored in file boxes or file cabinets to maintain their integrity. The quality records will be legible and kept in a location as to be readily retrievable by personnel and where agreed available for evaluation by the customer or customer's representative for an agreed period. All quality documents will be available to personnel.

4.16.2.1.1 Quality records will be retained for a minimum of 3 years. When the documents reach this minimum retention period they will be reviewed by management and either destroyed or kept. If the documents are kept they will be reviewed on a yearly basis for disposition during management review. Internal audits will be used to monitor this process.

4.16.3 Responsibility

Management representative or appointed personnel

4.16.4 References

4.16.4.1 ANSI / ASQC Q9002-1994, 4.16

      1. Procedures
        1. 4.16 (QPM – 001)
    1. Internal Quality Audits

4.17.1 Policy

Matis Inc. plans and implements internal quality audits to verify and assess the operation and effectiveness of the quality system.

4.17.2 Key System Components

4.17.2.1 The scope of this policy includes all internal quality audit activity.

4.17.2.2 Audits will be prioritized and scheduled at management review meetings. Audits are prioritized using the statistical data provided from the corrective/preventive requests. Audits will be scheduled at the earliest convenient time for the audit team. Areas to be audited will be notified prior to audit.

4.17.2.3 All areas to be audited will be audited by personnel who are independent from the area being audited. All audits will be performed by trained personnel.

4.17.2.4 An audit checklist (QD-020) will be used to document audits, follow up actions, personnel involved in audits, corrective actions used and verification of results. All internal audit results will be review by the auditor, auditee and by management review. A corrective/prevention action request will be started if any nonconformances are found during the audit. The management rep. will perform any follow up needed with the auditee to insure conformance. These audit results will be review prior to follow-up audits.

4.17.2.5 Quality records of internal quality audit activity are maintained (4.17.4.2).

4.17.3 Responsibility

Quality Manager or appointed personnel

4.17.4 References

4.17.4.1 ANSI / ASQC Q9002-1994, 4.17

        1. Corporate Policy Manual, 4.16
        2. ANSI / ASQC Q10011-1994
      1. Procedures
        1. QPM - 001
    1. Training
      1. PolicyMatis Inc. ensures that training needs are identified and training isprovided to appropriate personnel.
      2. Key System Components
        1. The scope of this policy includes all personnel performing activities affecting quality.
        2. At Matis the management rep. is responsible to develop and maintain the mandatory training, skill, and education requirements for personnel. The requirements will be documented in the training matrix and job descriptions. A sign in form will be used to record completed training for personnel. This matrix will be reviewed on a yearly basis by management review .
        3. Training effectiveness and future needs will be addressed at management review meetings. Management will have access to and use all pertinent data and information available to asses the needs and effectiveness of training for each position.
        4. Quality records of Training are maintained. (Ref. 4.18.4.2)
      3. Responsibility
        1. Management rep. or appointed personnel
      4. References

4.18.4.1 ANSI / ASQC Q9002-1994, 4.18

        1. Corporate Policy Manual, 4.16
      1. Procedures
        1. 4.18 (QPM – 001)
  1. Servicing
    1. Policy
    2. Matis Inc. does not have any services required by contract.

      Thus this section and its requirements are not applicable at this time.

    3. Key System Components
    4. Responsibilities
    5. References
    6. Procedures

4.20 Statistical Techniques

4.20.1 Policy

Matis Inc. identifies and uses statistical techniques for establishing, controlling and verifying process capability and product characteristics, where required, and as an element of continuous improvement efforts.

      1. Key System Components
        1. The scope of this policy includes all processes affecting quality.
        2. The management rep will be responsible to implement and maintain the techniques which will be used to monitor and control process variation and verify process capability and performance called out by quality planning. These techniques can be, but not limited to bar charts, bell curves, pie charts, pareto charts, sample plans, inspection reports, or techniques requested by the customer. Customer requested techniques will be documented by quality planning.
        3. The management rep will be responsible to use but not be limited to pareto charts as a statistical problem solving technique to support distribution, production, corrective and preventive actions. This process will be reviewed during management review meetings.
        4. Statistical quality control techniques which are used to verify product quality will be documented by quality planning personnel.
        5. Where applicable inspectors will verify process capability through inspection of produced parts and maintain this verification during process development in accordance with the quality plan.
        6. Quality records of statistical techniques are maintained (4.20.4.2).
      2. Responsibilities
      3. Management rep. or appointed personnel

      4. References
        1. ANSI / ASQC Q9002-1994, 4.20
        2. Corporate Quality Policy Manual, 4.16
      5. Procedures
        1. 4.20 (QPM – 001)

GLOSSARY

Term

Accuracy

Benchmark Data

Capability

 

Certified Registrars

 

 

ConformityCorrective Action P/an

Customer

Design Failure Mode and Effects Analysis (DFMEA)

Design for Manufacturing and Assembly

Design Validation

 

 

Design Verification Plan and Report (DVPR)

Definition

A measure of the difference (bias) between the average of the readings from a measurement system and a corresponding benchmark or master.

The results of an investigation to determine how competitors and/or best-in-class companies achieve their level of performance.

Capability is the total range of a stable process's inherent variation. It is determined using data from control charts, Reference Fundamental Statistical Process Control.

Certified Registrars are qualified organizations certified by a national body (e.g., the Registrar Accreditation Board in the US.) to perform audits of the Quality System Requirements and to register the audited facility as meeting these requirements for a given commodity.

The fulfillment of specified requirements.

A Corrective Action Plan is a plan for correcting a process or part quality issue. The recipient of a product provided by the supplier.

An analytical technique used by a design responsible engineer/team as a means to assure, to the extent possible, that potential failure modes and their associated causes/mechanisms have been considered and addressed.

A simultaneous engineering process designed to optimize the relationship between design function, manufacturability and ease of assembly.

 

Testing to ensure that product conforms to defined user needs and/or requirements. Design validation follows successful design verification and is normally performed on the final product under defined operating conditions. Multiple validations may be performed if there are different intended uses.

A document which details a design verification plan and reports status of the verification. It lists the evaluation and tests required for a program and also reports the assessment and results of test for each evaluation performed.

Environment

Failure Mode and Effect Analysis (FMEA)

 

Functional Verification

Inspection

 

 

 

Nonconformance

 

Objective Evidence

Ongoing Process Capability

Organization

 

 

Parts Per Million (PPM)

 

 

Preliminary Process Capability

Preliminary Process Performance Studies

Environment is all of the conditions surrounding and affecting manufacture and quality of a part or product.

An analytical technique performed by design, manufacturing or quality control engineering to assure that all possible failure modes of a product, product system, manufacturing process or quality control system have been addressed.

Functional Verification is testing to ensure the part conforms to all customer and supplier engineering performance and material requirements.

An activity such as measuring, examining, testing or gaging one or more characteristics of an entity and comparing the results with specified requirements in order to establish whether conformity is achieved for each characteristic.

Nonconformance is product or material which does not conform to the customer requirements or specifications.

Information which can be proved true based on facts obtained through observation, measurement, test or other means.

Ongoing process capability is a long term measure of statistical process control, or process performance. Reference Fundamental SPC Reference Manual.

A company, corporation, firm, enterprise, or institution, or part thereof, whether incorporated or not, public or private, that has its own functions and administration.

PPM is a measure of process performance in terms of actual or projected nonconforming material. In general use, PPM defective is expressed as the proportion nonconforming (defective parts/total parts) times 1 ,OOO,OOO.

See Preliminary Process Performance Studies.

 

Preliminary Process Performance Studies are short-term studies conducted to obtain early information on the performance of new or revised processes relative to internal or customer requirements.

Procedure

 

 

 

Process

 

Process Failure Modes and Effects Analysis (PFMEA)

 

 

Product

 

 

 

QFD

Qualified

 

Quality

 

Qualify Manual

 

 

 

 

Quality Plan

 

 

Quality Planning

A specified way to perform an activity. A documented procedure usually contains: the purpose and scope of an activity; what shall be done and by whom; when, where and how it shall be done; what materials, equipment and documents shall be used; how it shall be controlled and recorded.

A set of interrelated resources and activities which transform input into output.

An analytical technique which identifies potential product-related process failure modes, assesses the potential customer effects of the failures, identifies the potential manufacturing or assembly process causes, and identifies significant process variables to focus controls for prevention or detection of failure conditions.

The result of activities or processes. Product includes service, hardware, processed materials, software, or a combination thereof. Product can be tangible or intangible or a combination of both. Product can be intended or unintended.

Quality Function Deployment

The status given to an entity when it has been demonstrated to be capable of fulfilling specified requirements.

The totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.

Quality Manual (also known as the Quality System Plan) is a document that describes the elements of the quality system used to assure customer requirements, needs and expectations are met. Quality manuals include responsibilities and authorities for each element of the quality system.

A document identifying the specific quality practices, resources and sequence of activities relevant to a particular product, project or contract.

Quality Planning is a structured process for defining the methods (i.e., measurements, tests) that will be used in the production of a specific product or family of products (i.e., parts, materials).

Quality Policy

 

 

Quality Record

 

 

Registered Suppliers/Subcontractor:

Registrar

 

Reliability

 

 

Repair

 

 

Rework

 

Service

 

Setup Verification

 

Simultaneous Engineering

 

 

Special Characteristics

The overall intentions and direction of an organization with regard to quality, as formally expressed by top management. The quality policy is one element of the corporate policy.

A document which provides objective evidence of the extent of the fulfillment of the requirements for quality or the effectiveness of the operation of a quality system element.

Registered Suppliers/Subcontractors are suppliers/subcontractors who have received third party IS0 9000 certification for the commodity supplied.

A Registrar is a company that conducts quality system assessments to IS0 9000 Requirements.

The probability that an item will continue to function at customer expectation levels at a measurement point, under specified environmental and duty cycle conditions.

The action taken on a nonconforming product so that it will fulfill the intended usage requirements, although it may not conform to originally specified requirements.

The action taken on a nonconforming product so that it will fulfill the specified requirements.

The results generated by activities at the interface between the supplier and the customer and by supplier internal activities, to meet customer needs.

Formal review of process start-up (including equipment, tooling, material and conditions) to ensure that acceptable parts will be provided.

Process by which all involved - particularly Sales, Product Engineering, Manufacturing Engineering, Materials Management and Manufacturing – work together to conceive, develop and implement new

product programs.

Product and process characteristics designated by the customer, including governmental regulatory and safety, and/or selected by the supplier through knowledge of the product and the process.

Special Processes

 

 

 

Stability

Statistical Process Control

Subcontractors

Supplier

Validation

Value Engineering / Value Analysis

 

 

 

Verification

 

Visual Controls

Production, installation and servicing processes requiring pre-qualification of process capability. This requirement is usually due to the inability to verify the process by subsequent inspection and testing of the product or where processing deficiencies may become apparent only after the product is in use.

The stability of a measurement system variation over time.

The use of statistical techniques such as control charts to analyze a process or its output so as to take appropriate actions, which achieve and maintain a state of statistical control and improve the capability of the process.

Subcontractors are defined as providers of materials, parts or services to a supplier.

The organization that provides a product to the customer.

Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled.

A planned, clean sheet approach to problem solving, focusing on specific product design and process characteristics. Where value analysis is employed to improve value after production has begun, value engineering is employed to maximize value prior to expenditures of facilities and tooling money.

Confirmation by examination and provision of objective evidence that the specified requirements have been met.

Visual controls are techniques for conveying information by visual means to observers so that everyone can easily understand whether current conditions are normal. Examples are floor markings, action boards, standardized work charts and color coding

Bibliography

ANSI 8402 – 1992 – Quality – Vocabulary, ANSI 1986

ANSI / ASQC Q10011 – 1994 – Quality System Auditing, ANSI, 1994

ANSI / ASQC Q9001 – 1994 – Model for quality assurance in design, development, production, installation, and servicing, ANSI 1994

ANSI / ASQC Q9002 – 1994 – Model for quality assurance in production and installation, ANSI 1994

ANSI / ASQC Q9003 – 1994 – Model for quality assurance in final inspection and testing, ANSI 1994

Corporate Quality Policy Manual, Matis Inc., 1995