Page 1

Ozseals Pty Ltd MANUAL CONTENTS

Ref: Contents Section: Procedures Manual Revision: 1 Date: 19/02/01 Page: 1 of 1 page

SECTION

DESCRIPTION

1

Introduction & Policies of Ozseals Pty Ltd

2

Procedures

3

Master Forms Register

4

Flow Chart Work Instructions

5

Management Team Meeting Agenda Calibration schedule & Gauge Register Quality Records Listing


OZ Seals Pty Ltd

QUALITY MANUAL

Title: Build Status Issue: 2 Page: 1 of 1 Date: 14/06/2001

BUILD STATUS ISO 9001 Ref.

4 4.1 4.2 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5

ELEMEMENT

ISSUE

Quality Policies

1

Quality Management System General Requirements General Documentation Requirements Management Responsibility Management Commitment Customer Focus Quality Policy Planning Responsibilities and Authorities Management Review Resource Management Provision of Resources Human Resources Infrastructure Work Environment Product Realization Planning of Realization Processes Customer Related Processes Design and Development Purchasing Production and Service Operations Control of Monitoring and Measuring Devices

2 2 2 1 1 1 1 1 1 1 2 2 2 2 2 1 2 1 2 1 2

Measurement, Analysis and Improvement General Monitoring and Measurement Control of Nonconforming Product Analysis of Data Improvement

CHANGES

Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results

OZ Seal section Ref. 1 2

Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results

2 2 2 2 2 2 2

Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results Updated due to internal audit results

Master Forms Register

N/A

3

Standard Operating Procedures

N/A

4

1 1 1

5

Management Team Meeting Agenda Quality Records Listing Calibration Schedule & Gauge Register

The signing of this Build Status by the Managing Director authorizes its use under the requirements of the international standard ISO 9001: 2000 Signed: Wilhelm Prinz Date: 19/6/2001 Managing Director


OZ Seals Pty Ltd

QUALITY MANUAL Title: Introduction Issue: 1 Page: 1 of 6 Date: 27/11/2000

SECTION A

Introduction to OZ Seals Pty Ltd Ozseals Pty Ltd was established on 4th December 1995. Initially the company was established as a company, acting as a hydraulic and pneumatic seal manufacturer with division in each state of Australia and world-wide. The company is a manufacturer of hydraulic and pneumatic seals made of various plastics and rubber raw materials providing seals as part of an overall service to various industries. Emphasis is placed on custom made sealing solutions with a very quick turn around. In order to facilitate this process, significant investments have been made in the development of seal manufacturing systems, including hardware and software development, which has enabled the production of state of the art and the most technologically advanced machine able seal manufacturing systems. The development of these systems, along with manufacturing processes of raw materials used in seal manufacturing makes OZ Seals Pty Ltd one of the world foremost suppliers of:  Custom Made Machined Seals  Seal Manufacturing Systems  Raw Materials The business has expanded to these three distinct areas and now employs approximately 15 people at its headquarters at 9/67-75 Garden Drive, Tullamarine. Our core business is the manufacture of specialized seals. This service is widely used where a seal is an integral part of a manufacturing process and a commercial replacement is not available, therefore causing costly down time. We can supply a machined seal as quickly as the same day where required. Stocks of some regularly used seals are also retained in stock. OZ Seal manufacturing systems and specific CNC software is also available, and can be purchased or leased depending on the customer’s location. Customers using this facility are known as our partners.


OZ Seals Pty Ltd

QUALITY MANUAL Title: Introduction Issue: 1 Page: 2 of 6 Date: 27/11/2000

SECTION B ORGANISATION CHART

OZ Seals Managing Director

Technical Manager (MD)

Seal Manufacture

Poly Manufacture

Director

System Supply/ Manufacture

Administration

Shift Supervisor Purchasing Store Control

Sales/Shipping

Purchasing

Operators

Responsibilities and authorities are defined in Quality Procedures and Standard Operating Procedures


OZ Seals Pty Ltd

QUALITY MANUAL Title: Introduction Issue: 1 Page: 3 of 6 Date: 27/11/2000

SECTION C QUALITY POLICY MANUAL Fundamental to all work performed by OZ Seals Pty Ltd is the assurance of our product and service quality prior to delivery to the end user. In light of this all our products shall be suitable for their intended purpose and conform to agreed customer specifications, standards or contract requirements. OZ Seals Pty Ltd has established a Quality Management System based on Australian Standard ISO 9001: 2000. It is our intention to meet and or exceed the requirements of this standard in all areas relevant to our operations and activities and establish effective systems to achieve excellence in all areas of our business. Our Quality Policy and specific objectives has been developed and is displayed throughout the company. This Quality Policy Manual forms part of our overall Quality Manual and is intended as a reference source and as the basis of internal audits, review and certification of our Quality Management System for accreditation to ISO 9001 – Quality Management Systems – Requirements. To ensure continued effectiveness of our Quality System and to promote a uniform approach to how we address the elements within the Standard, we have referenced Procedures that form part of our Quality Manual. These Procedures are basic to OZ Seals Pty Ltd and cover the key elements of the Quality System and have been implemented throughout the organization. All personnel are responsible for ensuring the requirements of the Quality Procedures are adhered to at all times. Continuous review of the Quality Management System by the Management Team is aimed at determining if our Policies and operating philosophies are still valid and that changing customer requirements are reflected in the companies operations. A formal auditing process is designed to detect any deviation from our requirements and to identify any corrections or modifications required and any opportunities for improvement. The entire system is reviewed on a yearly basis to determine the continued suitability and effectiveness in line with ISO9001: 2000. Records are maintained on the results of such review through reports and minutes with responsibilities assigned and follow up details. All records, test data and results detailing our methods are confidential. Where duty authorized by the Managing Director, records and information may be transferred to the customer were it forms part of the supply contract.


OZ Seals Pty Ltd

QUALITY MANUAL Title: Introduction Issue: 1 Page: 4 of 6 Date: 27/11/2000

Quality Objectives OZ Seals Pty Ltd is committed to supplying goods and services that fully meet and or exceed the customer’s requirements. The continued research and development of our products and services is a major step toward this. To achieve our objectives, OZ Seals Pty Ltd must first understand our customer’s requirements as well as our ability to meet these requirements. A strong and mutual relationship with our customers and suppliers is the key to ensure that clear understandings can be reached. Forward planning and prevention techniques are used to head of problems before they occur and by using preventive methods rather than reactive solutions for problem solving. Opportunities for improvement and the reduction of waste are always being sought, Investigated and acted on. Methods of verifying the achievement of our objectives include but are not limited to  Maintaining and improving the companies accreditation to ISO 9001  Measurement through Management Reviews  Review of customer requirements, complaints and service  Providing adequate resources to meet customer requirements  Involvement and commitment of everyone at OZ Seals Pty Ltd  Identification of continuous improvement opportunities  Reduction of the number of nonconformities  Continuous liaison with our customers to improve our performance OZ Seals Pty Ltd is committed to growth and continuous improvement through the use of our partner associations. Our goal is to become the leader in the manufacturing of machined seal technology thereafter sharing the information with our partners and improving the industry. Our goals and objectives are rapidly being realized, with our seal machining technology being used all over the world and with the advancements we are making with the machine process and the software design and continuous improvements, OZ Seals Pty Ltd can only move forward.


OZ Seals Pty Ltd

QUALITY MANUAL Title: Introduction Issue: 1 Page: 5 of 6 Date: 27/11/2000

OZ SEALS PTY LTD QUALITY POLICY OZ Seals Pty Ltd’s vision is to establish itself as an international developer, and manufacturer targeting the World market for state of the art machined seal technology. OZ Seals Pty Ltd is committed to customer satisfaction and service by providing products that are of the highest quality for their intended use. The quality and reliability of our products is the responsibility of all our employees. It is the policy of OZ Seals Pty Ltd to operate a Quality Management System to meet or exceed Australian Standard IS09001: 2000 and to that end consistent control is established, implemented and maintained. The Management of OZ Seals Pty Ltd expects all employees to contribute positively to maintain and improve the high standards of our products and services.

Wilhelm Prinz Managing Director Issued 27th November 2000


OZ Seals Pty Ltd

QUALITY MANUAL Title: Introduction Issue: 1 Page: 5 of 6 Date: 27/11/2000

LIST OF PROCEDURE & DOCUMENTS ISO9001 Ref.

ELEMENT` Quality policies

4 4.1 4.2 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 7 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5

OZ Seal section Ref. 1

Quality Management System General Requirement System General Documentation Requirements Management Responsibility Management Commitment Customer Focus Quality Policy Planning Responsibilities and Authorities Management Review Resource Management Provision of Resources Human Resources Infrastructure Work Environment Product Realization Planning of Realization Processes Customer Related Processes Design and Development Purchasing Production and Service Operations Control of Monitoring and Measuring Devices Measurement, Analysis and Improvement General Monitoring and Measurement Control of Nonconforming Product Analysis of Data Improvement

2

Master Forms Register

3

Standard Operating Procedures

4

Management Team Meeting Agenda Quality Records Listing Calibration Schedule & Gauge Register

5


OZ Seals Pty Ltd QUALITY MANAGEMENT SYSTEM

Ref: O.P 4.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 1 of 5 Pages

PURPOSE The purpose of this procedure is to establish and maintain a Quality Management System that meets and or exceeds the requirements of ISO 9001: 2000. SCOPE This document applies to the organisational structure; responsibilities, activities and resources to ensure Ozseals Pty Ltd products and services satisfy stated or implied needs. REFERENCES DOCUMENTS       

ISO 9001: 2000 – Quality Management Systems – Requirements OZseals Pty Ltd Policies OZseals Pty Ltd Procedures Quality System Audit Reports Order Processing Flow chart WI01 Billet production Flow chart WI02 Design Flow chart WI03

RESPONSIBILITIES AND AUTHORITIES The Management Team, which consists of the Managing Director, Production Supervisor and the Sales team are responsible for the Quality Policy and the overall management function, which determines and implements the Quality Policy, procedures, goals and objectives. 4.0 QUALITY MANAGEMENT SYSTEM 4.1 General requirements The Management Team has defined OZseals Commitment and policy for quality, which identifies the establishment, implementation and maintenance of our Quality Management System. A Policy Statement has been defined and signed by the Managing Director, which identifies these goals and objectives. The Policy Statement is displayed in the main office and on the factory floor. Necessary steps have been taken to ensure that the Quality Policy is understood, implemented and maintained by all employees. Management are responsible for ensuring that resources are available to support the operation and monitoring of processes. Work Instruction flow charts have been put in place identifying individual operations and methods including inspection, measurement and analysis activities


OZ Seals Pty Ltd QUALITY MANAGEMENT SYSTEM

Ref: O.P 4.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 2 of 5 Pages

Work instruction flow charts, when required, highlight the following key elements:   

The quality objectives to be obtained The specific procedures, methods and work instruction to be applied Suitable inspection, examination and audit programs at appropriate stages.

Through instructions and procedures, actions necessary to achieve planned results and continually improve the processes and product quality have been made. All outsourcing of product and or service is controlled through a receiving inspection to ensure product conformity. The supplier is advised of any defects identified during inspection and containment action is required. An action plan is required from the supplier, which identifies what improvement plans will be put in place to ensure product improvement. 4.2 DOCUMENTATION REQUIREMENTS 4.2.1 General A Quality Policy is displayed throughout the company as per section 4.0 The company’s Quality Manual exists in electronic form and is controlled and located on the mainframe computer. A hard copy of this manual exists for reference purposes only. To ensure the latest copy is always used the electronic copy is to be used at all times. To comply with ISO 9001: 2000, the Quality Manual contains all sections relevant to the OZseals requirements and the standard. A master Document Register is maintained containing copies of all forms and documents the company currently has in use. Records are maintained as per section 4.2.4 of this procedure. 4.2.2 Quality Manual The Managing director has prepared and maintains an approved Quality Manual in accordance with the requirement of ISO 9001: 2000. The Managing Director approves the documented quality management system procedures and instructions within the framework of the standard. Regular meetings of Quality Management Team, ensure the effective implementation of the documented quality system, procedures and instructions.


OZ Seals Pty Ltd QUALITY MANAGEMENT SYSTEM

Ref: O.P 4.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 3 of 5 Pages

Review consists of well-structured and comprehensive evaluations, which include: 

Findings of audits centered on various elements of the quality system.

The overall effectiveness of the quality management system in achieving stated quality goals and objectives.

Considerations for up-dating the quality management system in relation to changes brought about by improvement strategies, new technologies, quality concepts and market strategies.

4.2.3 Control of Documents OZseals have implemented documented procedures to control all documents and data within the quality assurance system to the requirements ISO 9001: 2000 which are at a minimum the Quality/Procedures Manual. Work Instructions, Standards, Specifications and Test Methods, External Customer Supplied Drawings or other information. Such information is available at appropriate manufacturing locations. Document and Data Approval and Issue It is the responsibility of the Managing Director or Nominee to ensure all documents and data is reviewed and approved prior to issue. The Managing Director or Nominee is also responsible for maintaining a Document Register that identifies the current revision status of all documents and that the latest issues of documents are available and legible at all required locations. Customer supplied Drawings/Data All documents or data supplied by external customers are recorded in the customers file including date of receipt, issue and distribution as appropriate. Customer supplied drawings shall be treated as controlled documents. Obsolete Documents The Managing Director or nominee is also responsible to ensure all obsolete documents are removed from point of issue. Obsolete documents are retained only for legal and or knowledge purposes and shall be clearly identified with an “Obsolete Stamp”. Document and Data changes Unless stated otherwise, changes to existing documents and data are subject to review and approval by the same functions or organizations that performed the original review and approval. Regardless of the function performing the review, the function shall have access to the relevant background information to perform the review and approval.


OZ Seals Pty Ltd QUALITY MANAGEMENT SYSTEM

Ref: O.P 4.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 4 of 5 Pages

When and where possible the nature of the change shall be identified in the body of the document or in an appropriate attachment. All changes or additions shall be in italics and any deletion in strikethrough. Deletions shall be removed on the next change. 4.2.4 Control of Records The Managing Director has the overall responsibility and authority for the approval and maintenance of the Quality Records system and the Quality Records Listing. Personnel listed on the Quality Records Listing have the responsibility and authority for maintaining quality records as nominated. Quality records are maintained to demonstrate the conformance of product to specified requirements and the effective operation of the Quality Management System. Records Listing A Quality Records Listing identifies all records that are deemed Quality Records, lists the method of storage and indexing, defines who is responsible for each Quality Record, states retention periods and method of disposal. The Quality Records Listing is retained and updated by the Managing Director or nominee. Access Access to Quality Records is generally limited to the personnel responsible for the Quality Records as defined on the Quality Records Listing. Some records contain sensitive information such as Personnel and training files. Such Quality Records are maintained in a secure area were access is limited to those directly responsible. Storage and Maintenance Quality Records are legible and are stored in such a way as to prevent damage deterioration or loss. Each department is responsible for storing their own records. Storage methods ensure that Quality Records are readily retrievable. Availability When specified by contract, Quality Records are made available to the customer or their representatives for evaluation purposes. Such records are retained for an agreed period.


OZ Seals Pty Ltd QUALITY MANAGEMENT SYSTEM

Ref: O.P 4.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 5 of 5 Pages

Quality Records Quality Records that are subject to this procedure include but are not limited to:         

Business plans Management team minutes Annual review minutes Contract Reviews Training/Personnel Subcontractors/Suppliers Drawing/spec changes Electronic drawing media (EM) Inspection & Test results

     

Process/Equipment Non conformances Internal Audit Corrective & Preventive actions Equipment maintenance (EM) Customer supplied product

Equipment Calibration (EM)

“Note” (EM) = electronically stored media Record retention A backup of the quality management system is retained off-site by the Quality Systems Facilitator. All documents shall be archived when they become Un-manageable or as appropriate and retained for the nominated period. Records are in sequential or chronological order. “Note” some reference documents may be retained within individual departments.


OZ Seals Pty Ltd MANAGEMENT RESPONSIBILITY

Ref: O.P 5.0 Section: Procedures Manual Revision: 1 Date: 19/02/2001 Page: 1 of 3 Pages

Purpose The purpose of this procedure is to document the management’s responsibility and authorities in relation to the development, implementation, improvement and maintenance of our Quality Management System in accordance with ISO9001: 2000. Scope This document applies to the organizational structure; responsibilities, activities and resources to ensure OZseals Pty Ltd product and services satisfy stated or implied needs and the continuing improvement of our Quality Management System. References Documents    

ISO 9001: 2000 – Quality Management System – Requirements OZseals Pty Ltd Policies OZseals Pty Ltd Procedures Management Team Meeting Agenda

5.0 MANAGEMENT RESPONSIBILITY 5.1 Management commitment The Management are committed the improvement of its Quality System and communicating the requirements to the employees. To this end, work instructions and flow chart are used to instruct employees on operation methods. A quality Policy has been established and is displayed throughout the company, which reinforces the company’s commitment, goals and objectives. Management Reviews are conducted on published dates and are scheduled on a minimum of once per year. However, this may be more often if the need arises. During the Management Reviews the level of resources shall be reviewed by any training that may be required. 5.2 Customer focus At all times the Management consider customer satisfaction ensuring that customer requirements are met and or exceeded. 5.3 Quality policy The companies Quality Policy statement has been written to ensure it is appropriate to the organization, includes a commitment to comply with customer requirements, ensures


OZ Seals Pty Ltd

Ref: O.P 5.0 Section: Procedures Manual Revision: 1 MANAGEMENT RESPONSIBILITY Date: 19/02/2001 Page: 2 of 3 Pages continual improvement of the Quality system, provides a framework for establishing and review of quality objectives. Management has communicated the Quality Policy to the employees and has displayed the Quality Policy throughout the company. The Quality Policy is reviewed at all times by the Managing Director. 5.4 Planning 5.4.1 Quality Objectives The Managing Director has set Quality Objectives, which are measurable. Due to the stringent requirements and tight specifications of our products a zero defect to the customer has been set. This is measurable through customer concerns. Refer Section 4 of 6 of the Introduction to OZseals. 5.4.2 Quality Management System Planning To ensure the planning of our Quality Management System is carried out to meet the requirements, a Quality Systems Facilitator monitors the progress and improvement and advises where improvements or corrections are to be made. When changes to the Quality Management System are made, the integrity is ensured through the use of internal quality audits and review through the management review process. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and Authority Responsibilities and authorities are defined by the use of quality procedures, position descriptions and work instructions. 5.5.2 Management Representative The Quality Representative is the Managing Director. In the absence of the Managing Director the Production Manager shall assume the responsibility and authority. The Quality Representative ensures that:   

Processes needed for the quality management system are established, implemented and maintained. Reports to top management when the Managing director is absent on the performance and any possible improvements of the quality management system Ensures the promotion of customer requirements to all employees.


OZ Seals Pty Ltd MANAGEMENT RESPONSIBILITY

Ref: O.P 5.0 Section: Procedures Manual Revision: 1 Date: 19/02/2001 Page: 3 of 3 Pages

5.5.3 Internal Communication The Managing director is responsible for communicating to the employees the effectiveness of the quality management system. This is performed through individual communication or via meetings with all employees. 5.6 Management review 5.6.1 General A Management Review is undertaken as a minimum once per year. The management review is used to ensure the continual appropriateness, effectiveness and stability of the quality management system and to identify opportunities for improvement. A review of the quality policy and objectives is also performed. 5.6.2 Review Input Inputs to the management review includes but not limited to the followings:       

Results of internal/external audits Customer feedback Process and product conformance Preventive and corrective actions Follow up actions from previous meetings Any changes that may affect the quality management system Any recommendations for improvement.

5.6.3 Review Output The output of the management review includes the followings:   

Any improvement of the effectiveness of the quality management system Improvement of any product related to customer requirements Any short fall or projected resource requirements


OZ Seals Pty Ltd RESOURCE MANAGEMENT

Ref: O.P 6.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 1 of 2 Pages

PURPOSE The purpose of this procedure is to ensure that there are adequate resources and all employees have adequate training, which will ensure that:  

The resources are identified to implement, maintain and continually improve the quality management system To enhance customer satisfaction by meeting customer requirements

SCOPE This document applies to all training and identifies:     

Basic training requirements for all duties The promotion of OZseals quality system to all employees How training needs are established Personnel whoa re responsible for maintaining the training program Records that show the level of training personnel have received

REFERENCE DOCUMENTS    

AS/NZS ISO 9001: 2000 – Quality Management Systems OZseals Pty Ltd Policies OZseals Pty Ltd Procedures Training records

6.0 RESOURCE MANAGEMENT 6.1 Provision of resource On an ongoing basis, the Managing Director reviews resources to ensure there are adequate personnel to implement, maintain and improve the quality management system. The focus is on ensuring the employees have the correct skills and training to complete the required tasks ensuring customer satisfaction with the end product. 6.2 Human resources 6.2.1 General All employees are employed relative to the skills they have. Only those applicants with the knowledge required for the specific job are employed. Ongoing specific training is given in any shortfall areas.


OZ Seals Pty Ltd RESOURCE MANAGEMENT

Ref: O.P 6.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 2 of 2 Pages

6.2.2 Competence, awareness and training To determine the level of competency of personnel, the Managing director reviews all applicants to ensure they have the correct skills required prior to employment. For those areas, which the employee does not have the skills required they are either trained internally or sent out for training. Training is evaluated by performance after the training is given. The Production Manager or nominee has this responsibility. On the job training is provided where required to ensure the employees are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives. All training is recorded and maintained as records. 6.3 Infrastructure OZseals Management has ensured that the required workspace and facilities have been provided to enable quality products to be produced. Only the best supporting services, equipment and software is used with a continuous improvement philosophy as this technology is also sold to our customers. 6.4 Work environment OZseals management has ensured that the work environment is relative to the type work that is performed. All facilities are based on requirements and are continually improved as these requirements change. With the growing of our technology the only improvements required will be to expand our premises to hold larger production facilities.


OZ Seals Pty Ltd PRODUCT REALISATION CUSTOMER-RELATED PROCESSES

Ref: O.P 7.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 1 of 2 Pages

PURPOSE The purpose of this procedure is to establish and maintain a Quality Management System that meets and or exceeds the requirements of AS/NZS ISO 9001. SCOPE This document applies to the organizational structure; responsibilities, activities and resources to ensure OZseals Pty Ltd product and services satisfy stated or implied needs. REFERENCE DOCUMENTS    

AS/NZS ISO 9001: 2000 – Quality Management Systems OZseals Pty Ltd Quality Manual OZseals Pty Ltd Procedures Qualities plans

7.0 PRODUCT REALISATION 7.1 Planning of product realization In planning product realization, OZseals determine each of the followings:    

The quality requirements for the product The need to establish processes, documentation, and provide appropriate resources The level of verification, validation, and inspection and test activities Required records showing evidence that the product meets requirements

7.2 CUSTOMER-RELATED PROCESSES 7.2.1 Determination of requirements related to the product On receipt of a request for quote form the customer, the sales department ensures they have all the details including the following:     

Customer specification Deliver requirements/ delivery timing Quantity required Any statutory, regulatory or safety requirements (I.e. used in food production) Any further requirements determined by OZseals

If any information is ambiguous or not supplied by the customer, the sales department will contact the customer for verification.


OZ Seals Pty Ltd PRODUCT REALISATION CUSTOMER-RELATED PROCESSES

Ref: O.P 7.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 2 of 2 Pages

The completed quotation will be faxed to the customer and where required, followed up by telephone. 7.2.2 Review of requirements related to product When an order is received, the sales department generates a work order. In generating the work order the following review will be undertaken:     

Ensure product requirements are defined Any difference form the original quote is resolved with the customer Ensure OZseals has the ability to meet the defined requirements Record outcome of the review on the work order/production sheet If no written order received from the customer, the requirements will be confirmed over the telephone

If the customer requirements have changed since the quotation was given then at the Managing Director or nominee discretion a new contract review may be undertaken. In most cases the customer has ordered a stock item part from a catalogue. In this case the only review will be for type, profile, quantity and delivery instructions. 7.2.3 Customer communication A relationship has been set up with the majority of our customers that ensures communication channels are used at all times ensuring that all information is provided. For sales enquiries and shipping only one person normally deals with the customer therefore all product information, enquiries, contracts or ordering handling and amendments are dealt with immediately. The Managing Director or nominee handles customer feedback, including complaints.


OZ Seals Pty Ltd DESIGN AND DEVELOPMENT

Ref: O.P 7.3 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 1 of 3 Pages

PURPOSE The purpose of this document is to outline the controls and techniques used for controlling design of products manufactured by OZseals Pty Ltd. SCOPE This procedure applies to all systems required to control the design of products and processes where OZseals have specific control over the design element. REFERENCE DOCUMENTS     

AS/NZS ISO 9001: 2000 – Quality Management Systems OZseals Pty Ltd Quality Manual OZseals Pty Ltd Procedures Qualities plans Work Instruction Flow charts

7.3 DESIGN AND DEVELOPMENT Responsibilities and authorities The Managing Director has the responsibility and authority for ensuring procedures to be in place and operating efficiently to control all aspects of the design control process. This shall also include ensuring all specified internal or external customer requirements are met. The internal quality auditing system shall ensure any changes to methods or procedures are capture, corrected, and included in the quality manuals and or work instructions as required. The Managing Director has the responsibility and authority for ensuring all employees involved in design control, including interfaces with other departments, are aware of their responsibilities and to ensure control and verification of the design process as set out in this procedure are followed at all times. 7.3.1 Design and Development Planning On receipt of a customer order, the sales team check if a hard copy of the specification ect has been received and if not request the information from the customer. A multi function team (MFT) meeting where deemed necessary, may be arranged to discus the project planning. The participants in this meeting can consist of any of the following personnel:   

Managing Director Sales Production manager


OZ Seals Pty Ltd DESIGN AND DEVELOPMENT

 

Ref: O.P 7.3 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 2 of 3 Pages

Design specialist as required Other personnel as required

Where OZseals are responsible for the complete job, the design and development planning is split into two stages. Stage 1 is to produce the material (if required). Stage 2 is to produce specifications using the computerized (PEPS) system (if required). In this case the new product side of the flow chart shall be followed. If only a modification to the style or type is required then the “product modified” is the only section of the flow chart to be followed. During each phase the design shall be reviewed as required by the Managing Director or nominee and responsibilities shall be assigned. Records of the planning and development shall be maintained. As each stage of the design work is completed, the records shall be updated. If any person or organisation highlights any problems, the Managing Director shall review the design progress and discuss methods for resolving any issues of problems. 7.3.2 Design and development input During the design process, all aspects of the design shall be considered including; functional and performance requirements, information derived from similar designs, statutory and regulatory requirements and ambiguous or conflicting requirements which shall be resolved with those responsible for imposing the requirements. 7.3.3 Design and development output Design output shall be verified against the original design input using the original computerized model, drawings, specifications, customer models or any other means, which are measurable.. 7.3.4 Design and development Review Throughout the process, from initial customer order, to the final product samples being produced; design reviews by the Managing Director or nominee are continually made. This enables any concerns to be raised whether it is internally, with customer requirements or suppliers of services for the particular job. The Managing Director or nominee maintains records of meeting minutes as appropriate. 7.3.5 Design and development Verification Throughout all stages of design, verification is made to ensure each stage output meets the design input. Records of verification and any changes or amendments are maintained. Ref: O.P 7.3


OZ Seals Pty Ltd DESIGN AND DEVELOPMENT

Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 3 of 3 Pages

As each stage is completed, production conduct dimensional, visual, hardness and surface finish checks as appropriate. Records of the checks are recorded on the appropriate inspection report form. 7.3.6 Design and development Validation Validation of the design against customer specification and requirements can only be performed by the customer. 7.3.7 Control of design and development changes All changes to the design of individual component shall be reviewed by the MFT before inclusion into the design. Records of changes shall be recorded. Any changes to the design shall be authorized by the Managing Director prior to implementation.

DESIGN CONTROL FLOW CHART Click on Link below or select from “main directory�


OZ Seals Pty Ltd PURCHASING

Ref: O.P 7.4 Section: Procedures Manual Revision: 1 Date: 19/02/2001 Page: 1 of 2 Pages

PURPOSE The purpose of this document to outline the controls and techniques used for ensuring purchased product conforms to the requirement of OZseals Pty Ltd. SCOPE This procedure applies to all purchased made by OZseals Pty Ltd REFERENCE DOCUMENTS     

AS/NZS ISO 9001: 2000 – Quality Management Systems OZseals Pty Ltd Quality Manual OZseals Pty Ltd Procedures Qualities plans Approved Supplier list

7.4 PURCHASING 7.4.1 Purchasing process The purchase of goods is the responsibility of the financial controller. On receiving a request for purchasing of product, the financial controller shall first select a supplier from the approved supplier list. Selection of the supplier is based on their ability to supply product in accordance with OZseals requirement. Suppliers are evaluated on a regular basis ensuring they have a quality management system or similar controls in place to ensure supply to requirements. 7.4.2 Purchasing information The financial controller shall consider the following when raising a purchase order:     

Product type Quantity Requirements for approval of product, process, procedures or equipment Any Quality Management System requirements Delivery requirements

After completing the purchase order, the financial controller will review the purchase requirements prior to communication to the supplier.


OZ Seals Pty Ltd PURCHASING

Ref: O.P 7.4 Section: Procedures Manual Revision: 1 Date: 19/02/2001 Page: 2 of 2 Pages

7.4.3 Verification of purchased product On receipt of purchased goods, the person taking receipt shall check the goods against the delivery documentation and purchase order prior to placing in stock. Records of receipt inspection are recorded on the Receipt Log. Verification at the supplier premises is not currently a requirement of OZseals. Any goods not conforming to OZseals requirements will be isolated and the problem communicated to the supplier for resolution and preventive action.


OZ Seals Pty Ltd PRODUCTION and SERVICE PROVISION

Ref: O.P 7.5 Section: Procedures Manual Revision: 2 Date: 19/02/2001 Page: 1 of 2 Pages

PURPOSE The purpose of this document is to outline the controls and techniques used for production and service provision at OZseals Pty Ltd. SCOPE This procedure applies to all production, processes, identification and traceability, customer property and preservation of product at OZseals Pty Ltd. REFERENCE DOCUMENTS     

AS/NZS ISO 9001: 2000 – Quality Management Systems OZseals Pty Ltd Quality Manual OZseals Pty Ltd Procedures Customer supplied product tag Inspection and I.D label

7.5 PRODUCTION AND SERVICE PROVISION OZseals control and provide production and service provisions using the following methods:     

Full product specification including product characteristics Supply of work instructions/flow charts Suitable equipment Supply of measuring devices Inspection criteria prior to dispatch

7.5.2 Validation or processes for production and service provision Raw material is validated prior to use by checking for porosity, splits or defects in the material. After the product is machined the product is again checked for these defects and also burrs, nicks, cuts and surface finish or imperfections. OZseals also validate the processes as by:      

Checking to defined criteria for the approval of the process Qualifying equipment prior to use or shipment Ensuring personnel are trained to perform the function Using specific work instructions/flow charts for processes Maitaining records Revalidating processes when problems are identified


OZ Seals Pty Ltd PRODUCTION and SERVICE PROVISION

Ref: O.P 7.5 Section: Procedures Manual Revision: 2 Date: 19/02/2001 Page: 2of 2 Pages

7.5.3 Identification and traceability All products are identified prior to shipment using an inspection I.D. label. Traceability may be made using this label and or the purchase agreement and delivery information. As our products are unique, product traceability is not normally an issue. 7.5.4 Customer property No customer supplied product is used at OZseals. However, if customer supplied product were to be used, it is the Managing Directors responsibility to put procedures in place to protect the product from degradation, loss or damage. 7.5.5 Preservation of product All products are protected from degradation, damage or loss until delivered to the customer. This is performed as follows:     

All goods are individually wrapped were possible Large seals are wrapped and packed in cardboard Small seals are packed in plastic bags Heavy consignments are wrapped and packed in boxed Raw material may be wrapped and boxed or shipped as is


OZ Seals Pty Ltd CONTROL OF MONITORING AND MEASURING DEVICES

Ref: O.P 7.6 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 1 of 4 Pages

PURPOSE This Procedure details, the methods, documentation and records used by Diecraft to ensure all measurements made b Diecraft or their suppliers are within an acceptable degree of certainty. SCOPE This procedure covers all the equipment used to verify product conformance including inspection and workshop measuring and test equipment. REFERENCE DOCUMENTS       

AS/NZS ISO 9001: 2000 – Quality Management Systems OZseals Pty Ltd Quality Manual OZseals Pty Ltd Procedures Calibration Schedule Calibration history Reference Label Calibration Label

7.6 CONTROL OF MONITORING AND MEASURING DEVICES DEFINITION ACCURACY – a qualitative term describing the degree of closeness with which the indications of an instruments approach the true value of the measurement. (Note: the quantitative expression of this concept should be in terms of uncertainty). CALIBRATION – comparison of a standard measurement, or an instrument of known accuracy, with other instrument or gauge in order to detect any variation in the measurement achieved. Depending on the nature of the instrument under calibration, any detected variation may be compensated by physical adjustment or recorded for subsequent arithmetical compensation. Calibration results are always to be recorded to provide a history of the long-term stability of the instruments. EXPIRE DATE – the precise date obtained from the calibration history of the instrument and requited after each re-calibration of the instrument which terminates the period of permitted usage prior to the next-qualification. GAUGES/INSTRUMENT – equipment pre-set as manufactured to define a fixed or set dimension.


OZ Seals Pty Ltd CONTROL OF MONITORING AND MEASURING DEVICES

Ref: O.P 7.6 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 2 of 4 Pages

Measuring and Test Equipment – all devices used to inspect or examine products to determine their compliance with specification, either by putting a numerical value on the feature being inspected or by comparing it with an independently established criterion. Standards Reference Measurement Standards – standards of the highest order of accuracy in a calibration system, which are used to establish the basic accuracy values of that system. Transfer Measurement Standard – designated measuring equipment used in a calibration system as a medium for transferring a basic value from a reference standard to lower echelon transfer standards or directly to measuring or test equipment. Interim Standard – an instrument used as a standard until an authorized standard is established. UNCERTAINTY OF MEASUREMENT – that part of the expression of the corrected result of a measurement which defines the range of values within which the true value, or if appropriate, the accepted true value is estimated to lie. Control of reference standards STORAGE AND USE – these standards shall be stored, maintained and used under controlled conditions. This will also apply to interim standards. USE RESTRICTION – the use of equipment designated, as a standard is restricted to those personnel authorized or responsible for control of the standards. Calibration history For each individual gauge or equipment etc. the calibration history lists the following information:      

Name and brief description of equipment Identification, serial numbers, etc Source to which calibration is traceable The location where the equipment is normally kept The calibration interval at which the equipment is to be checked for calibration The gauge error (if any)


OZ Seals Pty Ltd CONTROL OF MONITORING AND MEASURING DEVICES

Ref: O.P 7.6 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 3 of 4 Pages

7.6.1 PROCEDURE To maintain the company’s reputation for good reliable workmanship, it is essential to achieve consistent accuracy of manufacture both in-house and at sub-contractor’s premises. This can only be assured by the process of checking all measurements are within the drawing/ specification requirements and that all such measurements are capable of withstanding independent scrutiny to internationally accepted standards. This procedure delays down the requirements which are to be followed I order to ensure that all measuring equipment (new, modified, repaired, overhauled or reconditioned) meets the requirements of the relevant drawing(s) specification(s) prior to use. It is the responsibility of the Production Department to verify this compliance and, considering the equipment design, construction and usage, to define the maximum interval between calibrations before accuracy can be expected to vary significantly. The Production Manager is responsible and has the authority for maintaining a system whereby the following data is available for each piece of equipment under the calibration system:      

Device Name Instrument serial number Frequency of calibration Details of usual storage location Any notes as to method of calibration Record results of each successive re-calibration provide a history of the instruments performance over time.

The Production Manager has the responsibility and authority to identify measurements to be made, (Products and Drawings), accuracy required, (Calibration History) and applicable equipment required to perform verification activities. 7.6.2 Calibration status indication The calibration status of measuring equipment is controlled by the calibration history system. All inspection measuring and test equipment is identified with the suppliers unique ID No. This number is traceable to the records kept on the history records. The Production Manager, listing all the equipment that requires re-calibration and the date for re-calibration generates a calibration schedule. The equipment is re-calibrated when the due date falls. Inspection measuring and test equipment is identified with calibration stickers that provide for the date of calibration, the next calibration due date and the initials of the person who calibrated the equipment.


OZ Seals Pty Ltd CONTROL OF MONITORING AND MEASURING DEVICES

Ref: O.P 7.6 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 4 of 4 Pages

Equipment that is not subject to calibration is identified with a sticker that reads “calibration not required” or “reference only” Should a piece of equipment be found out of calibration the production Manager assesses and documents the validity of previous inspection and test results by:   

Reviewing the calibration history of the equipment Assess the area of use and function of equipment including inspection and test activities Any instance of product non-conformance that was later identified.

In exceptional circumstances, a calibration period may be extended but only with the agreement of the Production Manager. 7.6.3 General considerations Calibration of equipment is performed by the Production Manager under controlled conditions to the extent necessary to ensure that the calibration is acceptable. Employees that use inspection, measuring and test equipment have been trained in the use, handling and care of such equipment. Equipment is stored in appropriate storage areas, i.e. generally in boxes or cartons, to ensure the equipment fitness for use is maintained. Where applicable, equipment and or software are safeguarded from unauthorized adjustment that would invalidate the calibration setting. Test hardware such as templates, jigs and fixtures are also included n the calibration system. Any Customer supplied gauges shall be registered on a Customer Supplied Gauges List. Unless otherwise specified at contract review time, calibration of these gauges in the responsibility of the customer. Gauges will be used until recalled by the customer or the gauge is suspect, in which case the customer is notified. The Production Manager shall maintain the list. 7.6.4 Records The Production Manager maintains calibration records. The records include:   

Revision following engineering changes (If appropriate) Gauge condition and actual calibration readings Notification to customer if suspect material has been shipped.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 1 of 10 Pages

PURPOSE The purpose of this document is to outline the controls and techniques used for demonstrating conformity of product, the quality management system and the continual improvement of the quality management system at OZseals Pty Ltd. SCOPE This procedure applies to monitoring and measurement of product and processes, customer satisfaction, the control of non-conforming product, corrective and preventive action, analysis of data, internal audits and continual improvement. REFERENCE DOCUMENTS      

AS/NZS ISO 9001: 2000 – Quality Management Systems OZseals Pty Ltd Quality Manual OZseals Pty Ltd Procedures Internal Audit Register Internal Audit Checklist Non-conformance report (QPR)

8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General OZseals Pty Ltd ensures procedures are in place for the monitoring and measurement of product and processes and customer satisfaction. To control non-conforming product, corrective and preventive action and the analysis of data. To perform internal audits and strive for continual improvement. 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction OZseals Pty Ltd monitors customer satisfaction through direct contact with the customer. Due to the complexity of our product range and the limited quantity of product produced per order 100% inspection is performed followed by a confirmation check by a second operator. Due to this inspection, it is very rare that product is not to customer specification or requirements and therefore customer satisfaction is maintained. In the event a customer complaint is received it is the responsibility of the sales team to contact the customer directly and sort the matter out. In the majority of cases it has been found to be an error on the customers’ side with a wrong specification or incorrect information supplied. Refer O.P. 5 for further action.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 2 of 10 Pages

8.2.2 Internal Audits Responsibilities and authorities The Managing Director is responsible and has the authority for ensuring that internal audits are taken in a systematic and periodic manner in accordance with the requirements outlined in this procedure. Additionally, the Managing Director or nominee develops and maintains the audit schedule on an annual basis. The Auditor is responsible for actually conducting the audit in the prescribed manner and is independent of the area to be audited. The auditor also must ensure that where possible the function to be audited receives notification of the audit at least on (1) week prior to the audit. Auditee has the responsibility to be open and helpful during the internal audit process and to provide the necessary information and or documented evidence of activities being performed. Audit schedule An audit schedule for each Quality System Element used at OZseals is issued at not less than early intervals. All functions or elements shall be audited at least once a year. Provision is made for UN-scheduled audits (as required). The planned audit schedule may be increased if internal/external non-conformances or customer complaints occur. Audit procedure An auditor is appointed by the Managing Director who shall then conduct the internal quality audit in the following manner: Audit Preparation The Internal Auditor will develop a checklist or use a copy of the procedure etc. based on the content of the Quality Manual, Quality Procedure Manual. Work Instructions and or flow charts as appropriate. The checklist shall contain a description of the specific points to be covered with reference to procedures, programs, plans and standards that will form the basis for the audit. If a copy of the procedure is used, the auditor highlights the areas which to base the questions on. Notification The audit team may notify the auditee in writing or verbally, of the impending audit giving where possible at least 7 days clear notice to ensure availability of the auditee and any one else who may need to attend.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 3 of 10 Pages

Pre-Audit Meeting A Pre-Audit Meeting is held to discuss the details of the audit with the function involved. During this meeting, the people to be interviewed are identified. Performing the Audit During the audit, interviews are held with selected members of the function being audited, and an examination of relevant documents is undertaken. The Audit checklists or procedure are used to define the degree of compliance with the quality requirements desired; non-conformances/Process improvement opportunities are recorded on Quality Problem Reports (QPR’s). A sequential numbering system is used to identify the audit I.e.7.6/01 would represent “element 7.6 audited 2001”. QPR’s cross-reference the audit number so that corrective actions are traceable. Audits may also identify a need for corrective action or opportunities for improvement. Post-Audit Meeting A Post-Audit Meeting is held to discuss the result of the audit as well as those items requiring corrective action. All QPR’s are tabled and all observations/non-conformances discussed, including immediate corrective actions (documented on the audit report) and a scheduled response date. The Auditor will summarise findings, then assign a number, register, and sign and date all QPR’s. The Auditor will detail results, QPR’s raised, etc. on the audit report. Audit report After review and signature by the Auditor the audit report is given to the Managing Director for filing. The audit report shall be considered closed at this time. Further distribution of the report will be noted on the Audit Report when required. Corrective Action The person responsible for taking or directing the corrective action is identified on QPR’s. Corrective action is to be accomplished by the Auditee. The adutiee must respond to the QPR by the agreed due date and provide and estimated completion date (ECD) as part of the response. Follow up The Managing Director or nominee will maintain a QPR Register. If there is no response to the QPR or the scheduled action is not completed by the estimated completion date, the Managing Director and/or the Auditor will determine the reason for delay.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 4 of 10 Pages

Audit Close Out The Auditor shall verify that actions documented on the QPR’s are completed and acceptable by tracking the QPR’s when the ECD falls due or when the person gives notice that action has been taken. The audit is considered closed at the completion of the audit and the necessary actions are followed up with the QPR’s as required. Auditor Qualifications Any employee who is to become an Internal Quality Auditor must first attend a training session on internal auditing. Reference is made to AS 3911.2 – Qualification criteria for auditor. Audit of Related Results Product and processes are not directly audited, but product is subject to continuous inspection activities and the processes are deemed correct if the product conforms. Housekeeping Audits The production Manager or nominee performs housekeeping/safety audits. The Production Manager retains the house keeping audit results. 8.2.3 Monitoring and Measurement of Processes Process monitoring of machined product is performed using the Pets computer aided design software. Once the form type is selected in the software the overall sizes are input b the operator. The software then generates the correct algorithms for producing the part. No operator input is then required. For raw material process monitoring, the operator visually checks the process to ensure the process flow chart is followed at all times. No other monitoring or measurement is required. 8.2.4 Monitoring and Measurement of Product The Planning department has the responsibility and authority for producing the production schedule in accordance with customer orders/requirements. The Production Manager has the responsibility and authority for:    

Flow of work through the manufacturing process Ensuring that all the relevant information is available and in place Monitor the manufacturing operations and resolve problems Provide on the job training and develop the skills of operator.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 5 of 10 Pages

All personnel have the responsibility and authority for receiving inspection (who ever takes receipt of the goods. The Production Operator has the responsibility and authority for in process and final inspection activities. An independent person also performs a second inspection on the goods and signs them off before shipment. The Managing Director or nominee has the responsibility and authority to ensure that the procedures are in place and adhered to. Operators have the responsibility and authority to perform work as directed and to notify the Production Manager of any problems, concerns or non-conforming product. Production planning The Sales team of customer order the Sales team reviews and enters the schedule into the mainframe computer as an order entry. If there are any concerns, the customer is contacted for clarification. Upon completion of the review the customer schedule is produced and the order is written on the schedule board. The production schedule generates production part timing/lead time. The Sales team then raises a production works order on available raw material stock to cover customer requirements. Manufacturing process The operator checks the part for conformance. The job must not be passed on to any further operation until the part has been verified and approved. On the 1st run jobs or when a new Operator is used, the Production Manager provides verbal instructions and practical demonstrations to the Operator, and stays with the Operator until the Operator has displayed adequate competency in performing the required operations. In Process Inspection is performed by the Operator. The Production Manager may also perform validation checks. The operator indicating in process inspection and operation completion completes the Pass/I.D. label. When the operation/job is completed it moves onto the next operations or to a subcontractor or becomes a finished product. Sub-contract operations may include raw material production, machining, painting, welding, machine supply etc.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 6 of 10 Pages

Product sent out for sub-contract operations may be subject to receiving inspection upon their return. Non-conforming products are handled in accordance with section 8.3 – Control of nonconforming product. Accepted product is either placed in stock or shipped to the customer. It is the responsibility of the Sales team to package goods and prepare them for shipment. The operator packs all small sized seals in plastic packets as the job is completed. The Sales team packs all large items in heavy cardboard or boxes to ensure they are protected from damage and or deterioration. Workmanship standards Workmanship standards are clearly defined through the use of written instructions, glow charts, and Drawings. 8.3 Control of Nonconforming Product All employees of OZseals Pty Ltd are responsible for reporting any materials or products found to be suspect or nonconforming. Production Manager has the responsibility and authority for segregating suspect and nonconforming product. Raising QPR’s where required and issuing labels for control of non-conforming product. The Managing Director has the responsibility and the authority for the following:     

Maintaining control of the non-conforming product system Reviewing QPR’s and deciding dispositions in conjunction with Production Manager as required Follow up and close out of QPR’s Maintaining QPR’s as quality records Deciding whether corrective actions are required

Any goods or raw materials, which are identified as non-conforming products, are identified with a Hold Tag and segregated in the appropriate area, pending contact with the supplier/subcontractor to resolve the issue. QPR’s may be raised if required. In Process Products: Products found to be nonconforming are reported to the person in charge of the area concerned.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 7 of 10 Pages

The responsible person shall immediately complete and affix a Hold Tag or similar to the nonconforming product or its carrier/container, and where practical segregate the product. The responsible person shall then initiate a Quality Problem Report (QPR). The description of the non-conformance shall then be detailed int eh appropriate section of the QPR. The QPR shall then be forwarded to the Production Manager or a nominated delegate who shall:   

Receipt the QPR Decide the short-term corrective action Decide if corrective action is required

The Production Manager is conjunction with the Managing Director shall review the QPR and approve the required action by signing and dating the QPT prior to action implementation. Actions include:     

Rework to specification Use as is Return to supplier Sort Scrap

Non-conforming product that is reworked is subject to re-inspection upon completion to verify the effectives of the action. The occurrence of non-conforming product is recorded and tracked with a view to reduce such concerns. Items pending investigation or product in process or on hold such as at receiving are segregated from good product or material as appropriate. The Production Manager shall ensure that the agreed action is implemented before closure of any QPR, which has been raised. During the process of controlling non-conforming product, the Production manager shall, as is appropriate, direct the affixing and removal of I.D. labels or any other such identification. In the instance, that a small quantity of product is to be scrapped and the raising of a QPR is deemed inappropriate the scrapped parts are recorded on for management review. The production Manager has the responsibility and authority to make this decision.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 8 of 10 Pages

During all phases of the QPR preparation and resolution, the Production Manager or nominee shall update the QPR file with the new information as it is collected until it can be closed out. 8.4 Analysis of Data The Managing Director has the Responsibility and Authority for the analysis and use of operational performance related company level data. OZseals monitor customer satisfaction through telephone calls from the sales department. Minimal concerns are raised due to the 100% inspection performed on all products. Conformity of product is not a concern as each product is individually manufactured and checked. The only rejects produced are during machine set-up and any seals which when inspected exhibit porous or split raw material. This information is fed back to the casting department. Subcontractors supply materials to specification, which is certified and batch coded. No concerns have been raised in this area however, should a concern be raise the supplier would be requested to supply written corrective and preventive action. 8.5 Improvement Should customer assessment show opportunities for improvement then the Management Team either take the appropriate corrective action or develop a continuous improvement plan to address the concern. Records are maintained of continuous improvement strategies and outcomes in the form of minutes. 8.5.1 Continual Improvement A program of continuous improvement has been put in place for product quality, service, timing, deliver, and productivity and where possible product characteristics. Regular meetings are held by the Management Team to discus possible improvements. 8.5.2 Corrective action The Managing director or nominee has the responsibility and authority for the implementation and maintenance f the Corrective and Preventive Action System. Additionally, the Managing Director or nominee ensures that the correct cause for problems is identified and that timely corrective and/or preventive action takes place.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 9 of 10 Pages

Corrective Actions are action taken to prevent the recurrence of an existing problem. All product non-conformances are advised to the Production Manager. System related problems found during audit activities are documented on QPR’s. The decision to raise QPR’s rest with the internal auditor: As a general rule only one problem will be raised per QPR. In the instance of a QPR being raised the steps to be used shall be as follows” The response to QPR’s is monitored via the response due date and estimated completion date, which are recorded on the QPR and QPR Register. Generally, the receiver or the QPR handles cause investigation but in some cases the investigation may require a structured team approach. I.e. multi disciplinary team. The Quality Management Team may decide to utilize a team problem solving approach when the magnitude or complexity of a concern warrants the use of such an approach. The Management Team as required will nominate the team. Methods used for team problem solving include but are not limited to:  

Brainstorming Flow charts

Quality system non-conformances When an approved Quality Procedure is not being followed (via audit or observation) it is brought to the attention of the Managing Director. Corrective action is then taken to ensure that the procedure is followed. Customer concerns The sales team reviews customer concerns/complaints. When deemed necessary these shall be subject to formal corrective actions. Returned product Product that is returned by the supplier is subject to review and analysis. Records of such reviews are retained and when deemed necessary corrective action is take to prevent recurrence.


OZ Seals Pty Ltd MEASUREMENT, ANALYSIS AND IMPROVEMENT

Ref: O.P 8.0 Section: Procedures Manual Revision: 2 Date: 14/06/2001 Page: 10 of 10 Pages

8.5.3 Preventive Action Preventive actions are actions taken to prevent an occurrence of potential problems. Mistake proofing methodologies are used to a degree appropriate to the magnitude of the problems and commensurate with the risks encountered. The use of various sources of information to identify potential problems and possible preventive actions is part of Quality Management Review Activities. Sources of information may include:      

Internal and external audit reports Customer complaints Supplier concerns Corrective action trends (QPR’s) Employee suggestions Knowledge and experience with processes

When the need for preventive action has been established it ma be documented on a QPR and follow the same steps. Permanent changes in methods and activities as a result of corrective action are documented in the relevant procedures or work instructions. Records The Managing Director or nominee maintains records of corrective and preventive actions.


OZseals

MASTER FROMS REGISTER

A.B.N. 79 066 727 553 Unit 9, 67 – 75 Garden Drive Tullamarine Victoria 3073


OZ Seals Pty Ltd

QUALITY MANUAL

Title: Document Register Issue: 1 Date: 27/11/2000 Page: 1 of 1

DOCUMENT REGISTER DESCRIPTION OZseals order/Quote Inspections & I.D. Label Daily Orders Received Report Material Order Production Sheet OZseals Tax Invoice OZseals Express Order OZseals Quotation Inspection Log sheet Approved Supplier List Non-conformance Report (QPR) Gauge Calibration Record

ISSUE 1 1 1 1 1 1 1 1 1 1 1 1

Manual Section 3 3 3 3 3 3 3 3 3 3 3 3

Order Processing Flow Chart Billet Production Flow Chart Design Flow chart

1 1 1

4 4 4

Quality Management Team Meeting Agenda Authorisation Matrix Quality Records Listing Gauge Register Compound List

1 1 1 1 1

5 5 5 5 5


OZ Seals Pty Ltd INSPECTION & I.D. SEALS

PROFILE: MATERIAL: DIMENSIONS:

QUALITY CHECKED

QUANTITY: DATE:

Sig ………….


INSPECTION LOG SHEET

LOG NO

WO NO

INS BY

DATE

OZSEALS PTY. LTD. DRAWING NO

PART NAME

ACC QTY

REJ QTY

DECRIPTION OF DEFECT

NCR

DISPOSITION


APPROVED SUPPLIERS LIST CAT

SUPPLIER

POSTAL ADDRESS

DELIVERY ADDRESS

PHONE No

FAX No

DEPT


NONCONFORMANCE REPORT (QPR) DATE……......................................................SERIAL NO.S………………………………………RAISED BY………………………. INTERNAL QUALITY AUDIT [ ]

CUSTOMER’S COMPLAINT [ ]

CUSTOMER SUPPLIED PRODUCT [ ]

NC PRODUCT [ ]

VENDOR [ ]

Tick or cross as applicable

SYS. ELEMENT/WORK INST. Nos OR NAME OF CUSTOMER OR PRODUCT (DRWING Nos.) OR SUB-CONTRACTORS NAME

………………………………………………………………………………………………………………………... ………………………………………………………………………………………………………………………… DESCRIPTION OF NON CONFORMANCE/POTENTIAL PROBLEM: (SEE ATTACH WHERE REQUIRED) …………………………………………………………………………………………………………………………………………………. …………………………………………………………………………………………………………………………………………………. …………………………………………………………………………………………………………………………………………………. …………………………………………………………………………………………………………………………………………………. …………………………………………………………………………………………………………………………………………………. SIGNATURE OF PERSON RAISING THE QPR…………………………………………….DATE…………………………………… RECIEPIENT SIGNATURE & DATE……………………………………… PROPOSED COMPLETION DATE………/…../…….. (Person taking the corrective preventative action) (no signature is required if faxed or sent to vendor or customer)

RESULT OF INVESTIGATION:

(See attached where appropriate) ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… SIGNATURE:………………………… DATE:…………………………….. REVIEW & DISPOSITION (this box is to be completed only for non conforming product) REWORK [ ] REPAIR [ ] CONCESSION [ ] USE AS IS [ ] REJECT/SCRAP [ ] RETURN TO VENDOR [ ] OTHERS: CORRECTIVE/PREVENTATIVE ACTION REQUIRED? YES/NO (if YES proceed to next section) SIGNATURE:……………………....... CORRECTIVE ACTION

DATE:……………………………..

………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… SIGNATURE:………………………… PREVENTATIVE ACTION

DATE:…………………………….

………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… SIGNATURE:………………………… DATE:…………………………….. FOLLOW UP VERIFICATION OF EFFECTIVENESS OF ACTION TAKEN:

………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………… CLOSED……………………………….

DATE:………………………………

This from is to be used for lodging non-conformances arising from internal quality audits; customer’s complaints, product non-conformance and any other complaint for vendors supplied product or customer supplied products. Any QPR issued or re-issued is to be logged in the register.


OZseals Pty Ltd Gauge Description, Number of I.D.

Gauge Type

GAUGE CALIBRATION RECORD Calibration Date

Measurement

Results

Acceptable Y/N

Action Required


QPR/NCE & INTERNAL AUDIT REGISTER QPR No. &/or Audit No.

DATE

RAISED BY

SENT TO

RESPONSE DUE

E.C.D

PART No./Description

CAUSE CODE

CLOSE OUT


CAUSE CODE: O: Operator Error T: Tooling M: Materials

S: Supplier Tr: Training H: Handling

I: Information P: Planning E: Equipment

Sys: System

HOUSEKEEPING/SAFETY AUDIT CHECKLIST Item SAFETY EQUIPMENT Extinguishers n place and marked Emergency exit signs Access to emergency equipment Evacuation plan displayed Emergency showers/eyewash MSDS available First aid kit Safety hazards marked Restricted areas marked Flammable materials marked Emergency contact names displayed BUILDINGS Lighting Ventilation Exits marked Doorways clear Damage to fittings/walls Services clearly marked

OK? Y/N

Comments

Corrective Action

Who

By When

Follow up


Grates Gutters/downpipes Vermin control STORAGE Shelves/benches tidy Sufficient rubbish bins Finished goods stored Portable tools stored Pallets stacked neatly Flammable liquids stored MACHINERY Clean under equipment Oil/water leaks Controls labeled Adequate guarding Guards in position Access for adjustments Emergency stops marked Noise Level AISLES/FLOOR Edges clearly marked Sufficient space width Tripping hazards Surface condition Water/oil leaks Clear of obstructions Clear of leads/hoses Clear of scrap and rubbish MATERIALS HANDLING


Trolley wheels mobility General Comments: Auditor Date Instructions for Housekeeping/ Safety audit:

Supervisor: Date

Managing Director shall appoint an auditor The Auditor completes the first three columns of the checklist Where problems are found the Auditor should be specific, e.g.: Oil spill at machine #. At the end of the audit, the auditor should discuss the findings with the Managing Director. Both shall sign the report. Audit findings are then discussed with the responsible person. Agreement on corrective actions and timing shall be made and recorded. The Managing Director may follow up or wait for the next scheduled audit to check the effectiveness of corrective of corrective actions taken, The Managing Director retians a copy of all House keeping/Safety audits as a record.


Quality Manual  

Quality Manual

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