1 RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE Quality Manual AS9100 & ISO9001: 2000 NTI/QM/001
2 CONTENTS Clauses of the standard Pg. # 1. Scope General Permissible exclusions 4 2. Normative reference 4 3. Terms & Definitions Product 4 4. Quality Management System General requirements Documentation requirements General Control of documents Control of records 6 5. Management Responsibility Management Commitment Customer focus Quality Policy Planning Quality Objectives Quality management system planning Responsibility, authority and communication Responsibility & Authority Management Representative Internal communication Management Review General Review input Review output 9 6. Resource Management Provision of resources Human resources General Competency, awareness & training Infrastructure Work environment 10
3 CONTENTS Clauses of the standard Pg. # 7. Product realization Planning of product realization Customer related processes Determination of requirements related to the product Review of requirements related to the product Customer communication Design & development Design & development planning Design & development inputs Design & development outputs Design & development review Design & development verification Design & development validation Control of design & development changes Purchasing Purchasing process Purchasing information Verification of purchased product Production & service provision Control of Production & Service provision Validation of processes for Production & Service provision Identification & Traceability Customer Property Preservation of product Control of monitoring & measuring devices Measurement, analysis & improvement General Monitoring & Measurement Customer satisfaction Internal audits Monitoring & Measurement of processes Monitoring & Measurement of product First article Inspection Control of nonconforming product Analysis of data Improvement Continual improvement Corrective action Preventive action 20 Glossary 21 Correspondence between ISO 9001:2000 and ISO 9001:
4 1. Scope RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE specializes in the precision Engineering of Aerospace parts. Our processes include 3D CNC machining, 3D programming, conventional machining. Our quality system has been written to the AS9100 & ISO9001: 2000 standard and has been certified by United Registrar of Systems. Note:- United Registrar of Systems (URS) is accredited by UKAS. 1.1 General RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has developed a quality system to ensure that our product is inspected and controlled for consistency to the specifications of our customers and regulatory requirements. RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE also has a system in place to review, evaluate and address customer satisfaction through a process of continual improvement and prevention of nonconformities. 1.2 Permissible exclusions The following sections of the ISO 9001: 2000 standard are not applicable to RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE 7.3 Design & development RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has no control over the design of the products supplied by the manufacturers or its authorized distributors. Our business is programming and machining. 2. Normative reference The following standards reference in the ISO9001: 2000 & AS9100 will be checked for their latest revision. If these standards should change this change will be notified to RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE through our Registrar (URS) and any effect this change might have. Below is a list of these standards:- ISO 9000: 2000 (This standard will be used for vocabulary and fundamentals) ISO (This standard is for guidance on design changes and is N/A at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE) ISO (This standard is for calibration) ISO (This standard is for conducting internal audits) A list of all other standards is controlled by RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE and is covered under procedure P4.0 & P4.1
5 3. Terms & Definitions The following terms and definitions will apply at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE Supplier Organization Customer Supplier = RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE suppliers Organization = RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE Customer = RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE customers 3.1 Product The term product used at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE is used to describe the Engineering and machining of parts to our customers specifications. The machining & Engineering services supplied are our product. 4. Quality Management System 4.1 General requirements To define how our Quality System is documented, implemented and checked to ensure it is understood. Policy All processes have been identified and documented within our quality system, the sequence and interaction of our operations are described below. The criteria and methods of operation have all been documented within the quality system with reference to information as required. All our processes are measured, monitored, analyzed and continually improved upon. 4.2 Documentation requirements General All procedures and documents needed to meet the ISO 9001: 2000 standard have been identified within this Quality Manual. These will be made readily available to all personnel who require them for their work and also to any customer or regulatory authority as required. (Ref: c AS9100)
6 4.2.2 Quality Manual This Manual shall be known as the Quality Manual. It will reference all procedures and will also show the sequence of operations and how they interact with each other. This manual is a controlled document and is subject to the controls outlined within section QUALITY SYSTEM STRUCTURE Quality Manual Operational Procedures Quality Records Control of documents (REF ISO94 sec 4.5) All documents (electronic and hardcopy) required for the quality system (internal & external documents) will be controlled as defined in P4.0 Document Control. All documents shall:- Be approved, reviewed and updated for adequacy prior to issue. The correct version of the document will be available at point of use All documents will be legible and remain legible through out the life of the document Documents will be readily identified and retrievable, this will include obsolete documents which may be kept for reference purposes and will be suitably marked. Any customer supplied digital data or hard copy data will be entered into the document control system the same as any other document for control of it s distribution and revision level and any other customer requirements. (Ref: AS9100) Any changes to any document within our quality system shall be reviewed in a timely manner to ensure correct implementation and distribution. A record of the incorporation of these changes shall be maintained and if required customers and regulatory authorities shall be informed. Ref: AS9100) Procedures Reference:- P4.0 Document control & P4.1 Control of cnc programs Control of quality records All quality records generated as a result of maintaining this quality system shall be kept as evidence of the effectiveness and compliance of the system. All records shall be identified and retained for a minimum of 7 years unless otherwise specified or required by contract. All records will be stored in a suitable environment so that they can be protected, retrieved and eventually disposed. All records shall be made available for review by regulatory authorities as required. (Ref: AS9100)
7 5. Management responsibility 5.1 Management commitment The Management at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has communicated the importance of this quality system, meeting customer, regulatory and legal requirements and will continue to do so to all employees. Some of the ways in which this is achieved are detailed below:- Regular reviews of our Quality policies and objectives Conducting management reviews Ensuring that adequate time, space, equipment, training and other resources are provided for. 5.2 Customer focus Top Management at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has the responsibility of ensuring that the customers needs are always identified and provided for. We do this at the top level within our Management review process by discussing concerns of our customers and special needs. This is then filtered down into the sales order process as specific customer needs and will be identified within the customer s order. 5.3 Quality Policy RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has committed to providing it s customers the best services from receipt of an enquiry through to completion of the job. This shall also include follow up with the customer to ensure that continual improvement is made to our processes. Objectives: Measure and determine the level of compliance to the quality system Use these measures to set forward thinking goals in all areas of the business Goals will include:- Increase sales while providing increased value to the customer Maintain on time order completion rate while ensuring the integrity of the product Maintain & foster good supplier relationships Detect any defective parts and prevent from shipping Ship 100% on time delivery Monitor and improve corrective action requests Continuously train and improve employees knowledge
8 The signatures below indicate acceptance, review and approval of all policies and objectives within this quality manual. Signed:- Chad Goforth President Signed:- QA Manager Date:- 8/22/2007 Date:- 5.4 Planning Quality Objectives Quality Objectives have been identified and are documented within the Management review procedure. These objectives are measurable and the results will be reviewed and adjusted to ensure that our Overall Company objectives are being met Quality Management System Planning RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has established a quality system, which is documented and implemented, this and the procedure(s) outline in Sec 7.1 will be our plan for ensuring quality. If changes in our organization occur which could affect our quality system these will be reviewed and planned for in advance and in a controlled manner. These changes will also form part of our Management review process 5.5 Responsibility, authority & Communication Responsibility and authority All of the persons at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE have their responsibilities defined within the procedures. Each person has been assigned with the authority to carry out their responsibilities. Each procedure within our quality system clearly shows how each function of our operation interfaces with each other. This is achieved through documentation of our processes. Any processes where there is only one individual who can perform that task will have an individual procedure written for them outlining their responsibilities and training requirements. (Ref: AS9100)
9 5.5.2 Management Representative The QA Manager has been appointed as the Management Representative. His responsibilities will include:- Ensuring that the Quality Management System is maintained Reporting to the President on the performance of the Quality Management System and areas for improvement Promoting awareness of quality and customer requirements to all personnel Liaison with the registrar. The Management Representative has the authority and organizational freedom to resolve quality related problems. (Ref: AS9100) Internal communication Communication between all personnel of the Quality system processes is achieved through documentation of the systems and regular meetings and reviews between all personnel. The Management representative will also be responsible for checking the understanding of the Quality Management System and that it is communicated. 5.6 Management review General To measure the continued suitability & effectiveness of our quality system. Our quality system will be reviewed by management on a twice yearly schedule against a prior set agenda. Minutes from this meeting will be kept (see 4.2.4) & any actions resulting from this will be carried out in accordance with sections & Review input Inputs have been identified as part of our set agenda for the Management review. These inputs include all of the requirements of the standard and a few extra ones Review output The output from the Management review will be recorded in the form of minutes and a list of action items. The list of action items will show:- any areas of system/process improvements, researching of new processes and equipment to meet customer requirements resource needs Objective and policy changes Procedures reference:- P5.0 Management review
10 6. Resource management 6.1 Provision of resources Resources will be provided by RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE to ensure that all processes are implemented and that any customer concerns are dealt with in a timely manner. 6.2 Human resources General All personnel at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be trained, educated, or have experience to ensure that they can fulfill their responsibilities Competency, awareness and Training To develop our most important resource: people through training and reviews of their progress, needs and the effectiveness of the training. Training will be carried out against needs which have been identified and this training will be recorded in accordance with section Also any tasks which are identified as requiring specific skills, training, education or qualifications will be provided for. Training will also be provided for the use, understanding and awareness of the Quality system and the standards used at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE (Ref: AS9100) Procedures Reference:- P6.0 Training 6.3 Infrastructure RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE Facilities are maintained, temperature controlled and clean. There is adequate workspace and equipment to perform all processes within the quality system. This includes control of the inspection & calibration areas. 6.4 Work environment The work environment is air-conditioned and each person is provided with a workspace and associated equipment and furniture to be able to perform their tasks. The work environment is controlled for temperature, humidity, lighting and cleanliness (Ref: b AS9100)
11 7. Product realization 7.1 Planning of product realization To plan, control, approve, monitor and set standards so as to prevent problems which may arise during Order processing, engineering, manufacturing, scheduled receipt, subcontract services and shipping. These processes will be scheduled, planned & carried out under controlled conditions & will include: (When/where applicable) Job Checklist Work Instructions Suitable working environment & reference to any standards applicable. Scheduling Inspection & checks and acceptance criteria Keeping records to support conformity of the processes. Any key characteristics identified by the customer as requiring tooling to measure variables will be provided for. Any in-process verification points that cannot be verified at a later stage will be identified on the Shop Traveler Any processes that require sub-contractors will be identified on the Shop Traveler The development of process controls and plans for key characteristics as required by the customer. The integration of material, processes and services which support the product will be identified on the Shop Traveler. (Ref: AS9100) Configuration Management If a customer requires configuration management of a product built at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE then the exact build of each job will be recorded and controlled by Job I.D # or customer part serial # s on each part and be maintained with the individual Shop Traveler. (Ref: AS9100) Procedures Reference:- P7.6 Receiving P7.7 Packaging & shipping P7.8 Production scheduling & Traveler flow
12 7.2 Customer-related processes Determination of requirements related to the product As part of our RFQ/Order process RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will determine what requirements are needed to fulfill the customers needs. These requirements will include:- delivery times engineering support regulatory & legal requirements are identified such as traceability & FAA clauses. Material selection Best method of manufacture Any requirements to review a Tender will be handled the same way as any other contract review. (Ref: AS9100) Review of requirements related to the product To ensure that our customers get what they requested on time, traceable and to the quality they expect from RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE all orders, quotations & enquires will be reviewed by RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE to ensure that; Customer s requirements are unambiguous, clearly defined & documented. changes to requirements are resolved with the customer, documented and communicated to all persons affected by the change. we can meet customer requirements. Any risks associated with new technologies, new materials or short lead times are evaluated (Ref: d AS9100) The records produced will be kept in accordance with section Customer Communication Communication between RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE and it s customers is to ensure that any updates, amendments, additions etc.. are handled effectively. This will include also any customer complaints, customer feedback and product requirements. Any contractual amendments are also subject to contract review. (Ref: AS9100) Procedures Reference:- P7.1 Receipt of Customer Orders Design & development These sections are permissible exclusions to our quality system.
13 7.4 Purchasing Purchasing process To ensure that RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE receives supplied product to our specified and implied needs a list of approved suppliers will be maintained and will also show the scope of each suppliers/sub-contractors approval. This list will be prepared on results obtained from one of the following sources:- SCAR s, questionnaires, audits or approved to AS9100/ISO9001 etc... Our purchases will also take into account physical condition of material/service, cost, availability and traceability. The purchasing system and the selection of suppliers will be reviewed to ensure its continued suitability and follow up action taken on vendor problems (see 5.6 & 8.3). Any sub-contractors used and the quality of the work that they provide will be the responsibility of RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE (Ref: AS9100) All suppliers and sub-contractors will be evaluated to ensure:- they use customer approved sources for any special processes any that fail to meet Newtech requirements are disapproved as required by the QA Manager suppliers/sub-contractor performance is monitored, maintained and recorded. These reviews will be used to determine the controls required in place for each supplier/sub-contractor. (Ref: d-g AS9100) Purchasing information (REF ISO94 sec 4.6.3) All purchase documentation used will clearly describe the material/service ordered including where applicable:- Quantities, condition, traceability, part numbers, type or other precise identification, Inspection requirements which will be reported on a certificate of Conformity where required. Also any standards/codes which maybe referenced Any quality system standard to be applied to the product/service. Any design, test, examination, inspection or customer acceptance requirement and it s related instructions The right of access by the customer, their customer and regulatory authorities to all facilities involved in the Order and also access to all applicable records. Any requirements for test specimens. Any requirements to notify RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE of any anomalies, changes in definition or approval for the process being used. Any requirements which require to be flowed down to sub tier suppliers will be identified on the document. All purchase documents will be reviewed for adequacy prior to issue. (Ref: d-h AS9100
14 Procedures reference: P7.4 Purchasing procedure P7.11 Approval & monitoring of suppliers quality systems Verification of purchased product All product received at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be verified in accordance with inspection procedures and may also include:- Records to support the quality of the product from the supplier (e.g.:- C of C, test reports, SPC charts etc..) Inspecting or auditing the supplier Inspection of the product upon receipt Asking the supplier/sub-contractor to complete inspection and certification, however if this is the case then this will be defined within the purchase documents. (Ref: AS9100) If verification of the parts is to take place by the customer at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE facilities or RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE chooses to verify the parts at the suppliers facilities, then this will be arranged and documented on the contract documents from the customer. 7.5 Production and service provision Control of production and service provision The production and service operations at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE are controlled to ensure that the following requirements are met:- Technical data is available to verify the parts being manufactured/supplied Procedures have been documented for all processes where required. Measuring instruments are used as required to verify product Compliance with reference standards / codes, quality plans and/or documented procedures. Monitoring of receiving, inspection, packaging & shipping processes. Criteria for workmanship other than those defined in any other documentation shall be called out on the "Shop Traveler" Equipment shall be suitable maintained to ensure continuing process capability. Key characteristics identified by the customers contract are monitored (These will be recorded on the Shop Traveler or inspection report. All material and parts will be accounted for during production, inspection and prior to shipping, this will include any Slit Orders/lots. The Shop Traveler will be used to record all operations and their sequence of completion Processes are in place to prevent, detect and remove Foreign objects Any utilities which can affect the quality of the product in the future will be
15 controlled. At present there are none. All jobs are completed using the supplied documentation attached to the Shop Traveler. This may include drawings and inspection plans, tooling required, CNC program references. If a Shop Traveler has to be revised to alter the process then these changes will be made by the originator and if required be identified back to the customer. The change and it s impact shall also be reviewed by Quality to ensure no adverse impact. When a CNC program is written it shall be validated by a 1 st article inspection as required. See First Article Inspection Any tooling which is held in storage for any amount of time shall be verified prior to use, these will be controlled through either the 1 st piece or final inspection process. Any work carried out at a sub-contractors facility will first be agreed with the Customer and then secondly be the subcontractors facilities will either be audited or the procedures defined for how to control their work. (Ref: AS9100) Validation of processes for production and service provision Most processes at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE can be verified using inspection results. Any special processes identified at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be qualified prior to use and their process parameters defined. (Ref: AS9100) Identification and traceability (REF ISO94 sec 4.8) RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will identify all parts during all stages of receipt, manufacture, inspection, packaging & shipping for traceability and its inspection status. All materials purchased will be traceable back to their source of supply if required by the customer. For example using a C of C. All goods received into RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be identified as to their inspection status by using accompanying paperwork. This is done at each stage of the Traveler. The inspection status will be recorded on the inprocess inspection report with an inspector s or operator's initials and date. If the customer requires by contract, regulatory or other established requirement that the parts be traceable then RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE shall provide the following where applicable:- The identification method shall be defined by the customer. Identification of parts throughout the life of the product Any batch traceability requirements, including scrap to be maintained and traceable to the raw material Any assembly traceability requirement to be traceable to the components and to the next higher assembly level. Any product that requires the sequence of production, inspection and assembly operations will be recorded on the Shop Traveler and kept as a record ref:-
16 The actual configuration of the built product will be kept as a record to identify any differences between the agreed configuration. (Ref:- 4.8 AS9100) The Inspection records shall also identify who the is responsible and authorized to verify, certify and release product. This will be indicated by an authorized signature which is controlled internally. (Ref: & AS9100) Customer property (REF ISO94 sec 4.7) To establish a documented system for receipt, control and maintenance of Customer Supplied Material (CSM). Documented procedures shall be established so that all CSM shall be examined, upon receipt, for damage, quantity, completeness and the correct material or characteristic. Any discrepancy shall be reported to the Customer whom supplied the materials. The necessary precautions taken and inspections performed to assure that no damage or deterioration occurs during storage. All CSM shall be identified and protected from unauthorized use or disposition. CSM will include, tooling, drawings, electronic files, parts and raw materials. Procedures reference: P7.5.1 Control Of Customer Supplied Materials_R0.doc Preservation of product To prevent materials being damaged and to control our inventory for maintaining an efficient cycle time on stock materials, RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will:- Handle materials to prevent damage, & deterioration problems. Materials will be controlled from receipt into storage and dispatch Any goods which are kept for any amount of time will be checked for shelf life/damage as required. All Orders will be packaged in accordance with procedures and customer requirements to prevent damage and to preserve the integrity of the original item. Our procedures will ensure that all goods are protected against damage and loss during shipping & receipt to customer. Records of shipments will be maintained in accordance with section Procedures shall also include, cleaning, Foreign Object Damage (F.O.D), any special handling requirements for sensitive parts, marking and labeling, hazardous materials as required. (Ref: AS9100) Also any documents which are required to accompany the shipments will be present, correct and protected from damage, loss and deterioration. (Ref: AS9100) Procedures Reference:- P7.6 Receiving P7.7 Packaging & shipping
17 7.6 Control of measuring & monitoring devices All measuring, test equipment which could affect the quality of the finished parts will be calibrated by an external sub-contractor or in-house in accordance with ISO & Traceable to the national institute of standards and technology (NIST). RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will also ensure that: Personnel will select appropriate equipment for the measurement to be made. All of this equipment and standards will be identified and calibrated. The sub-contractor will record details of equipment, identification number, location, checking frequency and method, tolerances and what to do when equipment is out of specification, when required by contract. Our equipment will be maintained in a suitable state of accuracy. All equipment will be in a known state of calibration. Records of calibration will be maintained (5.5.7). Our procedures will explain what to do with previous results when equipment is found out of calibration. All calibrations will be conducted in a suitable environment where necessary, temperature, cleanliness etc.. Our equipment will be handled, cleaned, maintained and stored accordingly. Adjustments to equipment will be controlled. Inspection, measuring and test equipment shall also include any personal tools used for final verification, also any hardware and automated test equipment. A list of all equipment shall be maintained within the Inspection department Any calibration result that indicates that product maybe non-conforming will require that the Quality Manager investigate the material and determine if disposition is required. Gauges are recorded in a spreadsheet by date and will be recalled by the QA Manager within a month of the due date. All responsibilities have been defined within the procedures for the control of the above referenced tools. (Ref: AS9100) Procedures Reference:- P7.10 Calibration overview 8. Measurement, analysis and improvement 8.1 General All materials will be inspected as it is received, machined and prior to shipping to assure conformity to the product and purchase order specifications. If statistical techniques are identified to monitor these activities these will be provided for. Any procedures identified shall include:- identification of authorized persons limits of authorization training & qualification requirements.
18 Inspection documentation shall be maintained as evidence of product & process conformance, these records shall show:- Acceptance & rejection criteria or reference to them. The sequence of operations on the Shop Traveler shall show when Inspection took place. Actual results Any unique inspection equipment shall be recorded on the Inspection record Any sub-contracted inspection activities shall be recorded and controlled in accordance with section (Ref: AS9100) 8.2 Monitoring and Measurement Customer satisfaction A procedure has been documented within our quality system to monitor customer feedback for positive and negative information. This information will be reviewed as part of the Management review and corrective action system to implement continuous improvement. Procedures Reference:- P8.1 Corrective Action Procedure Internal audits To verify the effectiveness of our quality system and implement any improvements RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has documented procedures to ensure:- Audits will be carried out against procedures and a schedule The schedule has also been set based on importance of areas to be audited. Follow up action and the results of these audits will be documented and reported. Records will be maintained of the audit in accordance with section All auditors have been trained and will be selected independent of the area to be audited. Audits will assess compliance to RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE procedures and also to the AS9100 & ISO9001: 2000 standards. The AS9100 checklist will be used to audit for compliance and determine our overall effectiveness. All auditors will be qualified and trained through a recognized training program. (Ref: AS9100) Procedures Reference:- P8.2 Internal audits Monitoring and Measuring of processes All processes at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be measured and monitored to ensure that they are suitable at ensuring the customer requirements are being met. This will be achieved through the internal audit
19 program and the inspection process Monitoring and Measurement of product All materials received, machined, stored, packaged and shipped from RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be inspected to procedures and a record of the results will be kept. Parts will not be processed in the system until all inspections have been completed unless the customer approves otherwise. If certificates of conformance/analysis are supplied and are to be used by RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE as acceptance of the parts, materials or service then these certificates are to be inspected to the specifications required by the contract. A sample of these test reports will also be independently verified on an annual basis as required by contract. (Ref: AS9100) The Inspection records shall also show actual results when required by contract or specification and also qualification of the product produced. All employees of RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE shall sign the R8.3 Inspection report data recording policy. Indicating that they have read, understand and will follow the policy described First Article Inspection Any 1st article inspections carried out at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will be carried out as follows:- They will be sent to the QC department for mark up of the key characteristics that are to be checked according to the contract or specification. These will be marked up either on the drawing with circles and numbers or as a list on the Inspection sheet. The actual results of the inspections will be recorded and any test results and required tolerances. Any production or process changes will require that the 1st article Inspection plan be updated by QC. (Ref: AS9100) Procedures Reference:- P8.3 Receiving Inspection P8.4 In-process & Final Inspection
20 8.3 Control of nonconformity To detect Non-conformance s and prevent them from being sent to the Customer, RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has documented and implemented a system procedure to:- Identify, "REJECTED", "RETURN TO VENDOR" or SCRAP parts Segregated where possible etc. and the problem documented. Review the problem to determine what to do with the goods. When this has been decided the persons concerned will be notified. Goods which are non conforming will be reviewed, categorized and documented and action taken. If a customer needs to return items then these will be issued an NCR # and tracked for disposition. These procedures shall also include the review and disposition of process nonconformities, the returns from customers and the notification of all persons required including customer, sub-contractor, regulatory etc... as required (Ref: AS9100) At Newtech a team approach to disposition of Non-conformances is used, the team is made up from Quality, Management and Production. They have the following disposition choses:- Use-as-is or repair (Only if authorized by the customer. Re-grading material which will require that the parts or material are clearly identified as re-grade and adequate test reports are available and updated to show re-grade. Scrap:- the parts or materials will be permanently marked or cut up to prevent re-use Any non-conformities discovered which may affect product already shipped or in use will be notified to the Customer in a timely manner. The notification will include a description of the parts, quantities, serial numbers and dates as required. (Ref: AS9100) Procedures Reference:- P8.1 Corrective Action Procedure 8.4 Analysis of data RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has systems in place to collect and analyze data from our quality management system. This data will include:- Results of internal audits NCR s from customers and SCAR s to the vendors Corrective action log RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will then use this data to make improvements to the quality system.
21 8.5 Improvement Planning for continual improvement RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE has a documented system in place which uses a planned approach to solving and implementing continual improvement. This continual improvement is tracked, documented and measured to the quality policy and it s objectives. Continual improvement is one of the agenda items at the Management review Corrective action A documented system procedure is established at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE for taking corrective action to eliminate causes of nonconformance, the action that is taken is also to a degree depended on the impact of the problem. Below is described the policy steps for corrective action at RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE:- The nonconformance is identified and documented The cause of the nonconformance is investigated and documented An action will be taken as appropriate to prevent the recurrence of the problem This action will also be documented Follow up on the effectiveness of the action taken will be completed as part at the next Internal audit unless it can be closed out earlier. If a sub-contractor/supplier is required to take corrective action then this will be documented using a SCAR and flowed down to them for action to be taken. If for any reason a corrective action is not effective or timely then specific actions will be instigated by the QA Manager and documented on the CAR issued. (Ref: e & f. AS9100) Preventive action RELIABLE TOOL AND MACHINE INC. / RELIABLE MACHINE & ANODIZE will identify areas of potential improvement and actions to be taken to prevent nonconformance. This will be done as part of our internal audit and Management review process. This process will include: - Identifying areas of potential nonconformance and documenting them into the corrective action system. Taking action appropriate to prevent the nonconformance Recording the results of the action and reviewing the effectiveness of the action taken. Procedures Reference:- P8.1 Corrective Action Procedure
22 GLOSSARY CONFIGURATION MANAGEMENT: The serialization of parts within an assembly. Correspondence between ISO 9001:2000 and ISO 9001:1994 ISO 2000 All rights reserved ISO 9001:1994 ISO 9001: Scope 1 2 Normative reference 2 3 Definitions 3 4 Quality system requirements [title only] 4.1 Management responsibility [title only] Quality policy Organization [title only] Responsibility and authority Resources Management representative Management review Quality system [title only] General Quality system procedures Quality planning Contract review [title only] General Review Amendment to a contract Records Design control [title only] General Design and development planning Organizational and technical interfaces Design input Design output Design review Design verification Design validation Design changes Document and data control [title only] General Document and data approval and issue Document and data changes Purchasing [title only] General Evaluation of subcontractors Purchasing data Verification of purchased product Control of customer-supplied product Product identification and traceability 7.5.3
23 4.9 Process control Inspection and testing [title only] General Receiving inspection and testing In-process inspection and testing Final inspection and testing Inspection and test records Control of inspection, measuring and test equipment [title only] General Control procedure Inspection and test status Control of nonconforming product [title only] General Review and disposition of nonconforming product Corrective and preventive action [title only] General Corrective action Preventive action Handling, storage, packaging, preservation & delivery [title only] General Handling Storage Packaging Preservation Delivery Control of quality records Internal quality audits Training Servicing Statistical techniques [title only] Identification of need Procedures