G & R Labs. Quality Assurance Manual. G&R Labs Scott Boulevard Santa Clara CA Light Meters and Calibration

Transcription

1 G & R Labs Light Meters and Calibration Quality Assurance Manual G&R Labs 2996 Scott Boulevard Santa Clara CA 95054

2 QM01 QUALITY MANUAL ISO9001:2008 Manual Contents QM 01 Manual Contents 2 QM 02 Copy Holder 3 QM 03 Distribution 4 QM 04 Table of Amendments 5-6 QM 05 Company Profile 7 QM 06 Quality Policy 8 QM 07 Organization & Responsibilities 9 QM 08 Elements & Requirements - ISO 9001: Manual revision 2 / Page revision 9 April 23, 2013 Page 2 of 23

3 QM02 QUALITY MANUAL ISO9001:2008 This document is approved for use Copy Holder Copy Holder: Quality Management System Representative Copy Number : 1 This quality manual Covers the activities and functions performed by G&R Labs, for operating areas included in the service scope definition for:- Design, Manufacture, Repair and Calibration of Light Meters. The Quality Management System is designed to meet the requirements of ISO 9001:2008

4 QM03 QUALITY MANUAL ISO9001:2008 Quality Manual Distribution Copy Number 1 - Quality Management System Representative Copy Number 2 - QAS International Ltd (Uncontrolled Electronic Copy)

5 QM04 QUALITY MANUAL ISO9001:2008 Amendments All copies of this quality manual must be kept under strict control to prevent the Quality Management System (QMS) from becoming corrupted / unreliable. The following procedures will ensure that the system remains current and valid. 1) All copies of the manual will be clearly numbered and the holder recorded. 2) Each page in the manual will carry its own number. 3) The Quality Management System Representative (QMSR) will be responsible for all revisions and additions being recorded. 4) Changes can be suggested by any Employee but must receive signed approval before being entered into the manual. 5) All changes must be recorded on the Amendments List (QM 04, Page 05 of 20) and appropriate pages in each manual changed. 5.1 Amended pages must be issued with a new issue number and new date of issue. 5.2 Amendments to the quality manual will be recorded on the Amendments List 6) The manual is not distributed in its controlled form to any other locations but may be issued in uncontrolled form to any location, 6.1 Any such requested the copies shall be clearly marked as "UNCONTROLLED Valid only on the Date of Issue" before distribution. 6.2 No records are maintained of issued uncontrolled copies of the manual.

6 QM04 QUALITY MANUAL ISO9001:2008 Table of Amendment Procedure Manual QM Document Number Page Number of New Issue No New Issue Date QM07 9 of 23 April 23, 2013 Change in responsibility Description of Change Authorization George Richardson Manual revision 2 / Page revision 9 April 23, 2013 Page 6 of 23

7 QM07 QUALITY MANUAL ISO9001:2008 Company Profile Some Facts about G & R Labs George Richardson has over thirty years of experience calibrating spectral responses ranging from 193nm to 780nm, and was the Co-founder and Vice President of Engineering of OAI for 12 years where he: 1. Implemented standards and calibration procedures 2. Designed the original meters for use in measuring photolithograph systems: steppers, projection, contact, flood exposure The UV standards, calibration procedures and UV light meters designed and manufactured were the direct results of George's experience and knowledge. Developed and implemented correct spectral response glass designs used to measure UV light today. G & R Labs is a direct extension of years of designing, manufacturing and consulting and it's business charter is to design and manufacture UV Light Meters and to offer calibration service to all existing UV light meters disregarding the manufacture of those meters.

8 QM06 QUALITY MANUAL ISO9001:2008 G&R Labs Services Quality Policy Statement We at G&R Labs are committed to understand, meet & when possible exceed our customer s requirements through the continuous improvement of our processes. We are dedicated to delivering defect-free product safely and on-time at the most competitive cost possible. We dedicate ourselves to provide Excellence, Quality, and Reliability. To ensure the policy is useful, G&R Labs employees will be responsible for identifying customer requirements and follow the correct procedures to meet those requirements. G&R Labs employees will help in improving the procedures and will follow the procedures set out by G&R Labs. G&R Labs Services will maintain the system by continuously reviewing and improving the procedures to make sure the customer always receives the best product at all times. G&R Labs Services will be committed to operating under the strict procedures set forth by G&R Labs. It will be the employee s responsibility to follow and improve on these procedures. We as a whole company must adhere and maintain our Q.C.S. G&R Labs Quality Policy is based on the following 3 fundamental principles: 1. Maintain an International Standard 9001: 2008; 2. Continuously improving on our quality procedures to ensure we conform to all customer requirements; 3. Always ensure that employees are able to perform their duties effectively through on-going training. Everybody within the company is responsible for the Quality within the company and for maintaining high standards. Signed :- Date : - (President) Manual revision 2 / Page revision 9 April 23, 2013 Page 8 of 23

9 QM07 QUALITY MANUAL ISO9001:2008 Organization and Responsibilities President Office Manager. Sales/Customer Contact. Quality/ Calibration Manager. Purchasing. Engineering. Receptionist/ Accounting/ Shipping & Receiving. Calibration Technician. Shipping & Receiving Probe/Meter Assembly.

10 Quality Management System Customer Sales & Marketing Organisation Management Planning Policy & Objectives Legislation, Regulations & Standards Main work Process (Summary) Customer Enquiry/Order Resources & Training Plan Work/Sign Appropriate Agreements/Arrange Sub-contractors Sub-contractors & Suppliers Routine Inspections/Check Work Complete Work Process Full details shown in Procedure Manual -PRM 06 ~ Production and Service Operations & other procedures Performance Measurement Internal Audit Non-conformance Corrective & Protective Action Collection & Analysis of Data Process Performance Customer Customer Satisfaction Management Review

11 Quality Management System 4.1 General G&R Labs, through the offices of the President is committed to maintaining an effective Quality Management System (QMS), to satisfy the requirements of the ISO 9001:2008 Standard, for the activities of the organization carried out at their site. This will be achieved by regular inspections, audits and reviews of the work processes and procedures, with corrective and preventative actions being implemented where necessary. Work and administration processes will be carried out against established procedures to ensure consistent achievement of quality for both products and service, in compliance with the ISO standard. No changes/deviations are allowed to these procedures unless they have been reviewed and authorized by the President to ensure that quality and compliance with the ISO standard are maintained at all times. Resources (staff, materials, machine time and test equipment) will be provided along with clear instructions, to ensure that customer orders are met on time and that they consistently meet the required product quality criteria/specifications. Where applicable, changes will be determined and made to the work processes to improve the product quality and delivery times, with the aim of increasing customer satisfaction. Changes will also include improvements to the organization s internal administration procedures to enhance order tracking from start to finish, purchases of materials and/or services, which will be controlled, and the ability to answer customer queries. All such changes to the QMS will be made through ongoing checking (monitoring, measuring & analysis) and review of the work processes to identify potential areas of realistic and achievable improvement and the necessary actions required to make such changes. (Refer also to Clause 8 Measurement, analysis and improvement) 4.2 Documentation G&R Labs has written its quality policy and procedures, as appropriate to its size, type and complexity. These are included in this quality manual and the procedures manual, which identify all documents and records required to maintain effective QMS control. The quality manual and procedures manual are made available to all employees G&R Labs has prepared and maintains this controlled quality manual that defines the scope of its activities, which is supported by referenced documented procedures and descriptions on how the procedures operate.

12 4.2.3 A documented procedure ensures that all relevant quality documentation is controlled, whereby no changes can be made to the quality manual, procedures manual, the internal quality manual forms and records and necessary external documents and records, without the authorization of the President. This control ensures that all changes stay within the requirements of the ISO 9001 standard and that they are adequate for meeting and improving the work (administration and production) processes. The status of the quality documents is identified by a title, reference number; issue number and issue date such that any changed documents can be easily identified. All such documents are legible, retrievable and located, where required, within G&R Labs. Obsolete documents are clearly identified and removed from circulation to prevent unintended use. Where necessary relevant documents and records originating from outside G&R Labs, then they are identified and their distribution is controlled to ensure that they are made available to those who need them in order to carry out their duties. All such external documents and records are filed and retained, as necessary to maintain an effective QMS control Procedures are in place to control the identification, issue, retrieval, storage, protection, retention time and disposal of all necessary quality records. Records will be legible, identifiable and retrievable. 5 Management Responsibility 5.1 Commitment The President ensures that all employees are made aware of the need to meet customer and regulatory requirements, and that all the necessary resources are made available to meet these requirements. The quality policy and objectives are reviewed and maintained by the President carrying out regular management reviews and making changes where they are required. 5.2 Customer Focus Customer needs and expectations, as regards product/service quality criteria / specifications, quantities required and delivery dates, are determined at the time of taking / accepting the order, in the knowledge that all their requirements can be and will be fulfilled to ensure customer satisfaction. Due consideration is given to service, regulatory and legal requirements at the time of making such commitments to the customer. Manual revision 2 / Page revision 9 April 23, 2013 Page 12 of 23

13 5.3 Policy G&R Labs is committed through its quality policy, to meet customer requirements, to continually improve its product/services quality and to maintain the QMS within the requirements of the ISO 9001 standard at all times. Quality objectives established to meet the quality policy are continually reviewed to ensure that they are suitable for meeting the quality policy and are communicated, as appropriate, throughout the organization. 5.4 Planning G&R Labs has established measurable quality objectives, which form an integral part in achieving and applying the quality policy. All personnel at all levels within the organization, who carry out production and/or administration duties to meet both the customers orders and compliance with the QMS requirements, are issued with clear instructions as regards meeting these quality objectives Adequate resources are made available, and output is planned in a controlled manner, to achieve the quality objectives and to meet requirements of the QMS, its processes and the need for continual improvement to the QMS. 5.5 Responsibility, authority and communication Management ensures that all staff is aware of their responsibilities, their levels of authority and their interrelations with other members of staff and that all of these are clearly defined and communicated within G&R Labs Management have appointed a nominated representative, from within G&R Labs, who has the authority and responsibility to ensure that the QMS is established, maintained and improved in a controlled manner. This Quality Management System Representative will report on the performance of the system and will ensure that all staff understands the significance and the importance of meeting customer requirements and complying with the QMS requirements Management has established an effective communications between all levels of staff and their various departments, to ensure that they are made aware of the effectiveness of the QMS processes. Manual revision 2 / Page revision 9 April 23, 2013 Page 13 of 23

14 5.6 Management Review The complete quality management system (QMS) is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review process will identify where changes can be made to make realistic and effective improvements to both the QMS and the quality objectives to enhance customer satisfaction. The review takes place at Management Review Meetings and the minutes of the meeting and arising activities/objectives are recorded for future reference The management review covers:- The evaluation of current process and service performance against quality objectives The results of internal and external audits Improvement opportunities Customer feedback, Changes that could affect product or service quality. Follow up actions from previous meetings From the management review, various decisions and actions will be identified, along with those responsible to complete the actions and target dates for completion, which will cover:- Corrective and preventative actions for non compliances. Improving the QMS and process efficiencies, Improving the product/service to enhance/improve customer satisfaction Resources needed to support the aforementioned improvements. 6 Resource Management 6.1 Provision of Resources G&R Labs has ensured that the necessary resources needed to implement and improve the Quality Management System (QMS) and to address customer satisfaction are made available, in the form of adequately trained staff, equipment, materials, facilities and supporting infrastructure. Manual revision 2 / Page revision 9 April 23, 2013 Page 14 of 23

15 6.2 Human Resources Management ensures that all staff, who are directly or indirectly tasked with conformity to product/service requirements, are adequately trained, experienced and qualified to effectively carry out their production and/or administration duties and to achieve their quality objectives The training needs required by all staff to achieve and maintain their QMS responsibilities and their quality objectives are identified and provided through appropriate training providers. Performance is evaluated to ensure that necessary competences have been achieved and appropriate training records are maintained. 6.3 Facilities/Infrastructure Management provides suitable equipped workplaces with appropriate production equipment, storage, materials handling, administration facilities, hardware, software and necessary information/supporting services. 6.4 Work environment The working environment is maintained in compliance with all applicable legislation, personnel working conditions and necessary requirements, to achieve product conformity as regards quantities, quality and storage. 7 Product/Service Realization 7.1 Planning of realization process The processes for the organization s products / services are planned and documented as defined in the QMS. In planning product realization the following are considered and identified:- Quality objectives, Resources required, including any special resources for specific products. Processes and associated documentation such as drawings and instructions. Verification/validation needs specified test criteria, measurement frequency of testing, test records, test equipment, calibration of test equipment etc. Document records to demonstrate that quality criteria have been achieved and maintained throughout the production process. Manual revision 2 / Page revision 9 April 23, 2013 Page 15 of 23

16 7.2 Customer related processes The needs of the customer in respect of product/service quantity, quality, delivery and post delivery activities are considered against the order requirements. Post delivery activities include warranties, maintenance agreements and contractual obligations. Where the product/service intended use entails compliance with applicable regulatory and legal requirements, which are not specified by the customer, then these are determined and implemented, where known G&R Labs reviews its customer s requirements and determines any additional requirements for each contract or order. Where no customer requirements are documented, then details are confirmed and documented before acceptance of the order. Any changes to contracts or quotations are resolved and documented before proceeding and any changes requested by either party during the process stage will also be documented and agreed. The company s ability to meet the customer order requirements is confirmed before acceptance of the order or any requested changes thereafter Effective communications are established with the customer in respect of:- Product/service information, Enquiries, order changes or amendments Customer feedback on order progress, including customer complaints. 7.3 Design and / or development The process of design or development of the product or process is planned and controlled to ensure that the product functions as intended and meets all user requirements. All aspects of the design are reviewed, with verification and validation against the unique purpose of the project carried out to ensure that outputs meet the design brief, including any statutory or legal requirements. The responsibilities and authorities of those staff responsible for design and development are identified within the organization. Manual revision 2 / Page revision 9 April 23, 2013 Page 16 of 23

17 7.3.2 The final product requirements are clearly defined through determination of all necessary inputs, which are all reviewed for adequacy and will include performance & functional requirements, consideration of previous designs/developments, applicable legislation/statutory requirements and any other defined/specified design and development customer specified criteria. Clarification of requirements will ensure that they are not unambiguous nor conflicting with each other The design /developments outputs are reviewed against the inputs and approved before release, whereby the preservation of the product is ensured in the review. Design/development output includes all necessary information for purchasing, production and servicing, as well as criteria for product acceptance and all essential specifications for its safe and proper use During the design/development process, systematic and planned reviews are carried out by all necessary organization and customer personnel, who have the knowledge and experience to ensure the effective completion and outcome of the project. Records of the reviews and designated actions are maintained Design/development verification outputs are verified against input requirements and records are maintained including necessary actions allocated to individuals in the organization and the customer Validation of the designed/developed product is carried out prior to the delivery or implementation where possible. Records of the validation are maintained including any necessary actions allocated to individuals Any required design/development changes are controlled, agreed with the customer and verified accordingly, with responsibilities and authorities defined and recorded. 7.4 Purchasing G&R Labs controls its purchasing function to ensure that the purchased products or services conform to requirements. Suppliers and their products are selected against defined criteria relative to their impact on the quality of customer order requirements. Suppliers are subject to planned review and evaluation. The results of evaluations and follow up actions are recorded. Manual revision 2 / Page revision 9 April 23, 2013 Page 17 of 23

18 7.4.2 Purchasing information/documents are reviewed before release to ensure that the required products or services are clearly described/specified before submission to the supplier, as regards:- Adequacy of information on products, services, procedures, processes and equipment Qualifications of personnel providing service functions Any other requirement, which will impact on G&R Labs QMS requirements G&R Labs verifies it s purchased products and services on delivery/receipt and where verification takes place at the suppliers premises, details of the required arrangements and the method of release are specified. 7.5 Product and Service provisions Products and services are controlled through use of:- Clear product & service specifications Work instructions. Suitable equipment, which is properly maintained Specified measuring and monitoring equipment and software, which are calibrated and/or tested, as applicable, before use. Clearly defined product release, delivery and post delivery processes Where validation of the product or service cannot be ensured during the process by measuring and monitoring, then control is exercised by specified qualification of the process, equipment and personnel, through defined methods, procedures, records and re-validation, where deficiencies are identified as a consequence of the product being used Where traceability is required, the unique identification of the product or service is controlled and records maintained, throughout the product realization process Where customer property and/or personal data is provided to G&R Labs for inclusion in the product or service, then it is identified, verified, maintained and protected with details of adverse condition reported to the customer G&R Labs preserves/protects the product or service from receipt of order to delivery and this also covers constituent product parts, where necessary. Preservation/protection includes, as applicable, processes for:- Identification Handling Packaging Storage Manual revision 2 / Page revision 9 April 23, 2013 Page 18 of 23

19 7.6 Control of measuring and monitoring equipment Where product conformity requires verification through use of measuring and monitoring equipment, then the organization identifies such needs. The measuring and monitoring equipment will have identification and will be controlled and tested to appropriate recognized standards for consistency and the results of calibration and/or verification tests are recorded The equipment is protected against random adjustments, damage and deterioration. Where software is used in the measuring and monitoring process, then it will be verified and configured to maintain its suitability for use. Where any measuring and monitoring equipment and/or software is found to be nonconforming to requirements, then appropriate action will be taken on same and any previous products retested. 8 Measurement, analysis and improvement 8.1 General G&R Labs plans and implements the necessary processes for monitoring, measurement, analysis and improvement processes needed to:- Demonstrate product conformity, Sustain QMS conformity Continually improve the effectiveness of the QMS. 8.2 Measurement and monitoring Customer satisfaction - Clear methods have been established, as part of the measurement of QMS performance,.to audit customer satisfaction and identify any failures to meet organization standards. Measuring and monitoring may involve the use of customer surveys to ascertain their perception of the product, data on delivered products, customer compliments or other comments/feedback. Manual revision 2 / Page revision 9 April 23, 2013 Page 19 of 23

20 8.2.2 Internal audits - Suitably trained and impartial personnel conduct periodic independent internal audits on a planned basis. All aspects of internal audits are recorded, reviewed and timely corrective action is taken, where necessary, to ensure that the QMS conforms to both the requirements of ISO and the organization established QMS requirements and that it is being effectively implemented and maintained Monitoring and measurement of processes - Processes affecting customer requirements are periodically monitored and, where necessary, measured to ensure that the intended purpose is being met. Selected methods are used to verify the ability of the processes to attain planned results and for the instigation of corrective and preventative actions, as necessary. The frequency, extent and type of measuring and monitoring processes is established and applied according to the impact, which the product has on the QMS Measuring and monitoring of the product The characteristics of the products are monitored and measured by the organization throughout the process, by authorized personnel who to ensure that the finished products or service meets specifications and that their release is both controlled and that appropriate records are maintained. 8.3 Control of nonconformity Documented procedures are in place to identify and isolate non-conforming products or services, where this is practicable Before the corrected or accepted non-conforming product is returned to the process, then it is re-checked. In the event of non-conforming product or service reaching the customer, appropriate corrective action is taken to advise the customer and negotiate the return and/or replacement of the product or service as necessary. The details of the non conformities, subsequent corrective and preventative actions taken and any concessions taken internally or with the customer are recorded and maintained. Manual revision 2 / Page revision 9 April 23, 2013 Page 20 of 23

21 8.4 Analysis of data Data referring to service quality problems is collected and analysed. Where identified changes to the QMS offer improvements, then these changes are introduced and monitored to verify the improvements. Areas for attention are:- Customer complaints, Meeting the customers needs, Product & service characteristics Supplier performance. 8.5 Improvements The QMS is managed in a manner to offer continual improvement having regard to statements in its quality policy, quality objectives, audit results, data analysis, corrective and preventive action and management review Appropriate actions are taken to identify the causes of the non conformities, to rectify the initial problems (corrective action) and to prevent their recurrence (preventative action see below) and the procedures are documented. Corrective and preventative actions are monitored to ensure that they are effective G&R Labs identifies preventative actions to prevent the recurrence of nonconformities on a long term basis and to offer potential improvements for the QMS. The results of such actions are recorded and reviewed for effectiveness. Manual revision 2 / Page revision 9 April 23, 2013 Page 21 of 23

22 Cross Reference ISO9001:2008 and Quality Management System Clause No Requirement Quality System Document Quality Manual Quality Manual Control of Documents Procedure PRM Control of Quality Records Procedure PRM Management Commitment Quality Manual 5.2 Customer Focus Quality Manual & Procedure PRM Quality Policy Quality Manual Quality Objectives Quality Manual Management System Planning Quality Manual Responsibility and Authority Quality Manual Management Representative Quality Manual Internal Communication Quality Manual Management Review. General Procedure PRM Management Review. Review input Management Review. Review output 6.1 Provision of Resources Procedure PRM Human Resources. General Competence, Awareness and Training. 6.3 Infrastructure 6.4 Work Environment 7.1 Planning of Product Realization Procedure PRM 06 Process Determination of Requirements Related to the Procedure PRM 04 Product Review of Requirements Related to the Product Customer Communication Design and Development Planning Procedure PRM Design and Development Inputs Design and Development Outputs Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes Manual revision 2 / Page revision 9 April 23, 2013 Page 22 of 23

23 7.4.1 Purchasing Process Procedure PRM Purchasing Information Verification of Purchased Product Procedure PRM Control of Production and Service Procedure PRM 06 Provision Validation of Processes for Procedure PRM 06 Production and Service Provision Identification and Traceability Procedure PRM Customer Property Procedure PRM Preservation of Product Procedure PRM Control of Measuring and Monitoring Procedure PRM 08 Equipment 8.1 General Procedure PRM Customer Satisfaction Procedure PRM Internal Audit Procedure PRM Monitoring and Measurement of Procedure PRM 12 Processes Monitoring and Measurement of Product Procedure PRM Control of Non-conforming Product Procedure PRM Analysis of Data Procedure PRM Continual Improvement Procedure PRM Corrective Action Procedure PRM Preventive Action Procedure PRM 11 Manual revision 2 / Page revision 9 April 23, 2013 Page 23 of 23