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
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)
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)
President or appointed personnel
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.
Management Representative or appointed personnel
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
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
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.
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
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
4.6.3 Responsibility
Purchasing Manager or appointed personnel
4.6.4 References
4.6.4.1 ANSI / ASQC Q9002-1994, 4.6
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)
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
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).
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
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.
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)
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.
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
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)
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.
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.
Management representative or appointed personnel
Matis Inc. ensures that products are controlled through handling, storage, packaging, preservation and delivery in such a manner that product integrity is maintained.
Purchasing Manager
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
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
4.18.4.1 ANSI / ASQC Q9002-1994, 4.18
Matis Inc. does not have any services required by contract.
Thus this section and its requirements are not applicable at this time.
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.
Management rep. or appointed personnel
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