Quality Systems Manual

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1 Hardy Machine & Design, Inc. Quality Systems Manual Meeting ISO9001:2008 Requirements Ankur Goel August 21, 2015

2 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 2 AS 9100 Quality Management Systems Table of Contents 1 Scope General Application References Terms and Definitions Quality Management System General Requirements Processes Documentation Requirements General Quality Policy Quality Objectives Quality Manual Control of Documents Control of Records Records Retention Time Management Responsibility Management Commitment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority, and Communication Responsibility and Authority Management Representative Internal Communication Management Review... 14

3 Quality Systems Manual Hardy Machine & Design Rev. 015 Page General Review Input Review Output Resource Management Provision of Resources Human Resources General Competence, Training, and Awareness Infrastructure Work Environment Product Realization Planning of Product Realization Project Management Receipt of Order Job Folders and Shop Folders Traveler System Setup Programming Material Purchase Raw Material Receiving Shipment of Customer Order Risk Management Configuration Management Control of Work Transfer Customer-Related Processes Determination of Requirements Related to the Product Review of Requirements Related to the Product Quotation Processing Customer Communication Design and Development Purchasing Purchasing Process Purchasing Information... 25

4 Quality Systems Manual Hardy Machine & Design Rev. 015 Page Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Production Process Verification Control of Production Process Changes Control of Production Equipment, Tools and Software Programs Post-delivery Support Validation of Processes for Production and Service Provision Identification and Traceability Customer Property Preservation of Product Identification / Marking and Labeling including safety warnings Handling Packaging Storage Protection Cleaning Prevention, Detection and Removal of Foreign Body Objects Special handling for sensitive products Shelf-Life Control and Stock Rotation Special Handling for Hazardous Material Control of Monitoring and Measuring Equipment General Equipment Identification Master Standards Adequacy of Master Standards Availability of Procedures and Equipment Environmental Control Calibration Procedures Calibration Records Subcontractor Control Inaccurate Gage Procedures... 35

5 Quality Systems Manual Hardy Machine & Design Rev. 015 Page Labeling and Recall Measurement, Analysis, and Improvement General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Product Product Recall Inspection Provisions Customer Source Inspections Control of Non-Conforming Product Non-Conformance Records Analysis of Data Improvement Continual Improvement Corrective Action Purpose Responsibility and Authority Procedure General Initiation of Corrective Action Origination Review and Implementation Preventive Action Purpose Responsibility and Authority Procedure General Initiation of Preventive Action Origination Review and Implementation... 46

6 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 6 9 Documents and Records Reference Quality Records Matrix Referenced Forms Organization Chart Job Descriptions President General Manager Quality Manager Quality Inspector Machine Shop Foreman Fabrication Shop Foreman Treasurer CNC Programmer Machinist Code Welder Pipe Fitter Shipping & Receiving Maintenance & Cleaning Management Review Committee Revision History... 53

7 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 7 1 Scope Hardy Machine & Design, Inc. of Houston, TX was formed in 1970 as a manufacturer of oil-field related parts and has been supplying precision machined parts to the wellhead, chemical, and industrial sectors. Hardy Machine & Design, Inc. has worked with the Department of Defense since 1985, with several logistical centers, and with prime contractors. Hardy Machine & Design, Inc. has the capability to start and finish every job it accepts due to a variety of equipment combined with the knowledge and experience of its personnel. As well as precision machining, Hardy Machine & Design is a complete welding, fabrication, and 3 rd party dimensional inspection facility. 1.1 General This manual covers Hardy Machine's implementation of the requirements of ISO9001:2008 quality management systems. The purpose of the quality management system is: 1 Demonstrate our ability to consistently provide product that meets customer requirements through the "Order Fulfillment" Process, as well as through secondary processes, such as "Gaging Practice". 2 Enhance customer satisfaction through effective application of the system described in this manual and by continual improvement of the system itself. We achieve continual improvement by performing and reviewing audits of the system. This manual will work in conjunction with Hardy Machine's Welding Quality Manual for use with ASME Pressure Vessel fabrication, but this manual does not cover the requirements associated with the ASME. Hardy Machine & Design, Inc. is compliant within the limited scope of machining in accordance with ASME Sect. III, NCA Application Hardy Machine currently excludes the following sections from this quality system: Section 7.3 ("Design and Development"). Currently, Hardy Machine is a contract machine shop that offers direct labor hours to machine and fabricate parts to our customer's designs. Any prototyping, designing, or development work is done in conjunction with our client's engineers who ultimately approve engineering designs. 2 References ISO9000:2005 "Fundamentals and Vocabulary". ISO9001:2008 "Requirements". 3 Terms and Definitions For the purposes of this manual, the following terms apply:

8 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 8 "Hardy Machine" This manual will use "Hardy Machine" as a short-hand for "Hardy Machine & Design, Inc." "Supplier" This manual will use the terms "supplier", "vendor", and "subcontractor" interchangeably. "Customer" This manual will use the terms "customer" and "client" interchangeably. "Key Characteristics" This manual will use term "key characteristic", "dimension", and "feature" interchangeably. 4 Quality Management System 4.1 General Requirements This manual establishes and documents the Hardy Machine quality management system. Section identifies the processes determined for the quality management system and their application through Hardy Machine, as well as determines their sequences and interaction. The rest of the manual determines the criteria and methods needed to ensure the operation and control of these processes, as well as monitoring and measuring the processes for planned results where applicable Processes Maintenance Training / Human Resources Accounting / Finance Customer Requirements Quoting Order Fulfillment Regulatory Requirements Core Business Non- Conformance Purchasing and Vendor Review Gaging Practice Associated Processes Internal Auditing Quality Systems Review Management Review

9 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 9 "Order Fulfillment" Order fulfillment covers the act of receiving orders, manufacturing them, and shipping them to the customer. Quoting The quoting process occurs before an order arrives, and estimates cost and lead time for manufactured parts. Maintenance Each machine used in the manufacture of parts is periodically maintenance to reduce unplanned downtime. The maintenance process determines maintenance requirements for each machine and schedules Gaging Practice Gages are used to measure all features of manufactured parts, and different gages are used depending on the required precision of tolerance involved. Gages must all be calibrated on a regular basis and traced to a master set of gages. Training (Human Resources) Personnel must be trained for the jobs they are performing. Performance and training are reviewed on a regular basis. Vendor Purchasing & Vendor Review Vendors perform direct and indirect actions on manufactured parts. Vendors are approved based on quality requirements and are reviewed on a regular basis. Accounting / Finance Accounting tracks order payments and makes sure money is available to implement the other processes. Non-Conformances Non-conforming product and non-conforming processes are tracked and recorded. Customer Requirements Customers who have specific needs of the quality management system will have those requirements documented and controlled by Hardy Machine. All employees shall be made aware of those requirements. Regulatory / Statutory Requirements Any requirements imposed by applicable statutory and regulatory agencies will have those requirements documented and controlled by Hardy Machine. All employees shall be made aware of those requirements. Internal Auditing Internal auditing checks the implementation of the quality system described in this manual. Management Review Using data from all of the above processes, management regularly reviews the effectiveness of the quality system.

10 Quality Systems Manual Hardy Machine & Design Rev. 015 Page Documentation Requirements General Quality Policy Hardy Machine & Design, Inc. works to provides world-class service to its customers. We seek to offer increasing levels of quality and faster delivery at competitive prices. We will continually improve our quality and service to make our customers proud to do business with us Quality Objectives 1. Record and analyze internal scrap rate on a monthly basis. This should be measured in both dollars of scrap and in volume of Non-conformances generated. Pareto analysis of scrap should trend down over time. 2. Record and analyze customer satisfaction based on quality and delivery. 3. Continually improve the quality system by improving processes to verify results. We are committed to maintaining a process management approach to drive the total quality management system by accelerating continuous improvement through teamwork, training coordination skills, and by focusing on consistent customer satisfaction through superior quality and service. Overall responsibility for quality system management rests with the President of Hardy Machine & Design, Inc. The Quality Control Manager (QCM) is responsible for the administration of the quality system. All personnel are vested with the responsibility for living the quality policy and for implementing the stated quality system during operations. Each employee of Hardy Machine & Design is required to acknowledge this responsibility by completing an Employee Acknowledgement Statement (Form 13) Quality Manual This manual will serve as the documented quality management system for Hardy Machine & Design. This document is subject to change and improvement as determined by management, but will always reflects requirements of the ISO9001:2008 standard. The quality policies and procedures found in this Quality Manual will be reviewed and amended as needed, when found warranted through the analysis of quality data, customer complaints, contract changes, or improvement suggestions. All documented procedures required by ISO9001:2008 are included in this manual, with the exception of the Internal Audit Procedure (Form 22) and Gage Calibration Procedures (Form 5) Control of Documents Documents required by the quality management system are controlled in various ways depending on the type of document. Hardy Machine uses Unipoint quality software as an electronic document control database. The following documents are stored in unipoint document control:

11 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 11 Forms Customer Specifications Manuals and Procedures Non-Conformances Corrective and Preventative Actions Unipoint allows the following controls via software controls: Only the General Manager and Project Manager has the ability to approve documents and their revisions added to unipoint document control, allowing him to ensure adequacy prior to use. Unipoint document control allows updating and review. Unipoint document control shows approval date and revision level for all documents. Unipoint document control is the only way to get access to these documents, and is available for the management team to use and make available at the point of use. Electronic documents stored in Unipoint document control are always legible and identifiable by document number. Unipoint document control allows Hardy Machine to note documents from an external origin, and that they are marked correctly. Unipoint maintains a master list of internal and external documents. Unipoint only makes available the most recent revision to any document in the system. Changes to documents can be noted several ways: Where appropriate, procedures will have a Revision History section that notes changes from one version to the next. If a Revision History section is inappropriate for a document, then those changes will be noted in Unipoint document control. Any changes to the documents shall be communicated to the customer and/ or regulatory agencies in accordance with contract or regulatory requirements. If changes to a document render a previous version obsolete, all effort will be made to dispose of the obsolete documents. Any obsolete documents retained will be marked "Obsolete" or "Old". Documents which are not stored in unipoint document control are controlled as follows:

12 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 12 Customer Drawings and Bills of Material Stored in hierarchical folder on electronic file server. Revision control handled manually by General Manager. Records Stored in Job Folders. Includes signed travelers, data sheets, MTR's, subcontractor certifications. (See Section 4.2.4) Quotations Stored in the same hierarchical folders on electronic file server as customer drawings. Travelers Stored in Syspro database. Maintained by General Manager for contract review purposes Control of Records Hardy Machine's records are maintained and controlled to provide evidence of conformity to requirements and effective operation of the quality management system. Records that are related to order fulfillment (production orders) are stored in Job Folders (see Section ). Other records are stored in locations as defined in Section 9.1. Job Folders provide control to maintain the following: Legibility all original records are stored in job folders Identification all job folders are stored by job number, which can be cross-referenced by customer, part number, purchase order number, and many other identifying features. Storage job folders are stored in temperature-controlled environments Protection job folders maintain all records in a single packet protected from unauthorized use and protected from deterioration. Retrieval job folders can be easily retrieved since they are indexed by job number. Retention time job folders are also indexed by age, and can be easily disposed after the specified retention time described in Disposition of records after the specified retention, job folders can be destroyed as a package. Any records created or retained by suppliers are also provided to Hardy Machine and stored in Job Folders. Records are available to customers and regulatory authorities for review in accordance to contract and regulatory requirements Records Retention Time All records specific to order fulfillment will be retained for at least seven (7) years, or longer if specified by customer requirements. All other records will have a retention time shown in Section 9.1.

13 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 13 5 Management Responsibility 5.1 Management Commitment The President of Hardy Machine shall be the driving force in implementing, maintaining, and improving the effectiveness of the Quality System. Evidence of the President's commitment shall be provided by: Communications to all employees of the importance of meeting customer as well as statutory and regulatory requirements. Meeting minutes, training records, newsletters, etc. shall be kept of such communications; Establishing the quality policy; Ensuring that quality objectives are established; Conducting Management Reviews of this quality system on an annual basis; and Ensuring the availability of resources. 5.2 Customer Focus The President shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction. This will be accomplished utilizing such methods as market/customer surveys (Form 10), industry reports, field reports, and outside sales reports. The President shall also ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be, achieved. 5.3 Quality Policy The President ensures that the Quality Policy: Is appropriate and reviewed for continuing suitability during management reviews; Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system; Provides a framework for establishing and reviewing quality objectives and ensuring that these objectives are consistent with the Quality Policy; Is communicated and understood within Hardy Machine; and Is review for continuing suitability. 5.4 Planning Quality Objectives The President ensures that the quality objectives in Section are measurable, consistent with the quality policy, and established at relevant functions and levels of Hardy Machine.

14 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 14 During the annual management review, the President will review these quality objectives to make sure they are consistent with the Quality Policy (Section 5.3) Quality Management System Planning Implementation of Hardy Machine's quality management system will be carried out in order to meet the requirements of the system as well as the quality objectives. Planning will ensure that any changes in the quality system manual are conducted in a controlled manner and that the integrity of the system is maintained during the change. 5.5 Responsibility, Authority, and Communication Responsibility and Authority The President ensures that responsibilities and authorities are defined and communicated within Hardy Machine. These responsibilities and authorities are communicated through organization charts, job descriptions, documented procedures, and training documents Management Representative The President has appointed the General Manager, a member of the management team, with the defined authority and responsibility to: Establish, implement, and maintain processes needed for the quality management system; Report to the President, annually, on the performance of the quality system and any need for improvement; and Promote awareness of customer requirements throughout Hardy Machine Resolve matters pertaining to quality management issues with the help of top management Internal Communication The President ensures that appropriate communication processes are established within Hardy Machine and that communication takes places regarding the effectiveness of the quality system. This communication takes the form of team briefings, meetings, notice boards, s, and formal reports. 5.6 Management Review General The President and his management team review the quality system annually to ensure its continuing suitability, adequacy, and effectiveness. The review assesses opportunities for improvement and the need for changes to the quality system manual, the adequacy of the quality policy, and the quality objectives Review Input Input to the Management Review includes information on: Results of internal and external audits,

15 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 15 Customer Feedback, Status of preventative and corrective actions, Follow-up actions from previous management reviews, Planned changes that could affect the quality management system, and Recommendations for improvement. Results of metrics from the Quality Objectives shown in Section Review Output The output from the Management Review includes decisions and actions related to: Improvement of the effectiveness of the quality management system and its processes, Improvement of products and their conformity to customer requirements, Resource needs. Recommendations for improving Quality Objective Metrics. Records of the management review are maintained in as a summary of the output described above. 6 Resource Management 6.1 Provision of Resources The President is responsible to ensure that resource needs are indentified and adequately provided: To implement and maintain this Quality Systems Manual while continually improving its effectiveness; and To enhance customer satisfaction by meeting or exceeding customer requirements These resources include, but are not limited to: People; Infrastructure; Work environment; Information; Suppliers; and

16 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 16 Financial resources. Personnel in each position with a function in this Quality System shall be qualified to establish requirements for that function based on appropriate education, training, skills, and experience. 6.2 Human Resources General Hardy Machine's management team will: Determine the necessary competence for new and current personnel performing work affecting conformity to product requirements. This shall be done through resumes, records of qualification, job descriptions, performance reviews, and observations; Provide training or take action to satisfy functional needs; Evaluate the effectiveness of those actions through observation and evaluation; Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives; and Maintain appropriate records of education, training, skills, and experience Competence, Training, and Awareness Hardy Machine will ensure that all personnel have the necessary training, background, and qualifications to perform assigned tasks contributing to product requirement conformity. Additionally, Hardy Machine will maintain Personnel Qualification Records (Form #4) and certificates of continuing education in the personnel files of persons who receive training. The General Manager will review these records on an annual basis. Any training activity will be documented on Form #4 Employee Training Form. This Form can be signed off by the General Manager, Project Manager, Shop Foreman, or Quality Manager. Hardy Machine will ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. 6.3 Infrastructure Hardy Machine will determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure will include, but is not limited to, the following: Buildings, workspaces, and associated utilities, Process equipment (including any necessary hardware and software), and Supporting services, such as communications services.

17 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 17 Infrastructure decisions will be documented during Management Review. 6.4 Work Environment The President, in consultation with employees, determines and manages the work environment needed to achieve conformity to product requirements ensuring that Hardy Machine also complies with any applicable regulatory requirements. Factors that may affect conformity of the product include temperature, humidity, lighting, cleanliness, protection from electrostatic discharge, etc. The machine shop will be temperature controlled to control temperature and humidity. Tight tolerance measuring devices will be stored under tighter temperature controlled conditions to mimic customers' environmental conditions (such as CMM and optical comparator). 7 Product Realization 7.1 Planning of Product Realization Hardy Machine will plan and develop the processes needed for order fulfillment. Planning of order fulfillment will be consistent with the requirements of the processes of this Quality Systems Manual. Order fulfillment planning will determine the following as appropriate: Quality objectives and requirements for the product, The need to establish processes and documents, and provide resources specific to the product, Any required verification, validation, monitoring, inspection, and test activities specific to the product and the criteria of product acceptance, Records, such as travelers and inspection checklists, that provide evidence of order fulfillment and product quality, Configuration management appropriate to the product, and Note: Quality Objectives and requirements include considerations such as: Product and personal safety Reliability, availability, and maintainability Producibility and inspectability, Suitability or parts and materials used in the product Recycling or final disposal of the product at the end of it life. The identification of resources to support operation and maintenance of the product. The output of this planning shall be a shop traveler, as described in the following sections Project Management Hardy Machine plans and manages product realization in a structured and controlled manner to meet requirements at acceptable risk within resource and schedule constraints. The sequence of operations is detailed from to

18 Quality Systems Manual Hardy Machine & Design Rev. 015 Page Receipt of Order Customer orders are processed as follows: 1. A purchase order for machined and fabricated parts can be received from customers via mail, fax, or . Additionally, purchase contracts can be agreed to between Hardy Machine and its customers for out-of-the-ordinary orders. 2. The original quotation that applies to the received order will be reviewed, if applicable, by the President or General Manager for verification of "as quoted" details. This will include checking for proper drawing numbers and drawing revisions of the order. If the order matches the quotation, Hardy Machine will transmit an order confirmation either via or fax to the customer. Any discrepancy between the quotation and order are reviewed and listed. If it is determined that a change order will be necessary, the client will be notified. 3. For any cost-plus projects, the drawings are reviewed for completeness and to ensure that Hardy Machine, its approved vendors, and its partners can handle the work. Tooling and fixture equipment are defined and reviewed. 4. The customer is informed immediately if Hardy Machine determines that certain parts of the work are beyond its capabilities or the capabilities of its vendors. Hardy Machine will work with the client, if required, to find a competent vendor for that work. 5. Any information not clear in the documentation with the order is reviewed with the customer. This can include drawings, specifications, delivery instructions, or post-delivery tasks. 6. Customer contact will continue as the project progresses to assure that all aspects of the job are understood Job Folders and Shop Folders Once an order is accepted, a job number is assigned to the order and then a job folder and a shop folder are created to store documentation as the order is being manufactured and after the order is delivered. The job folder is a permanent record of all documentation for a job, including purchase orders, sales orders, material certifications, incoming material reports, non-conformance reports, travelers, drawings, specifications, test results, quality control data sheets, and any other information or documentation that pertains to a job. These job folders are maintained by the Quality Manager. The job folder allows full traceability by linking the job number to customer purchase orders, vendor sales orders, material orders, individual part quality data sheets, and drawing records. The job folder information is available to a customer's representative for as long as the folder is maintained by Hardy Machine. The shop folder travels around the machine shop facility as material moves through the shop. The shop folder identifies which job the material is being used for, and is used by the machinists for instructions. Once a job is completed, the documentation is transferred to the job folder and the shop folder is discarded. The shop folder contains:

19 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 19 A job traveler with routing instructions and material requirements, A copy of the part drawing Any special instructions, including thread form data or internal drawings Traveler System Setup The shop traveler is prepared by either the General Manager or the Project Manager. It includes: A planned routing for each of the processes required for the job, including any necessary subcontracting work; Detailed work instructions for each work center involved in the manufacturing process, their quality goals, and their inspection requirements; A list of raw material needed to be released to the shop floor before work can begin, Final inspection and packaging requirements. The shop traveler will be updated based on the availability of work centers, changes in processes, or changes in vendors. These updates will be made as soon as possible Programming If a job requires the use of CNC work centers, the job is first sent to the CNC Programmer who follows these processes: He reviews the job folder to assess the programming needs. He will check to see if the job is a repeat, in which case he can use an existing program using the most recent update to the program. If a new program is written for a job, he will write the new program, assign tools, and design fixtures as appropriate. He will then ensure that all tools for the machines are available. If these tools need to be purchased, he will made a list and procure it himself. When the tools are received, the Programmer will verify that these are the same as requested. The Programmer will then submit all fixture requirements to the Shop Foreman, who will order material for the fixture. It will be made under the guidance of the Shop Foreman. The Programmer will assist the CNC machinists in setting all tooling and fixtures before the first article is run Material Purchase All material is purchased from Hardy Machine & Design s approved vendor list or from a client-approved vendor. When material is purchased, the following steps are taken:

20 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 20 The job folder is reviewed for material specifications and vendor requirements where applicable; Material purchase orders are made using either the customer purchase order number or job number as an identifier; Material purchase orders are placed in the job folder Raw Material Receiving When raw material is received, the following process is followed: Any material test reports received from the vendor are checked against the matching purchase order to verify accuracy; Received material is marked with its heat number, the client s name, the job number, the purchase order number, and, if required, the customer heat code number; Once material is received, it is moved to a designated job-staging area and will have the shop folder placed with the material. Material heat numbers or customer material code numbers are reaffixed to material anytime the manufacturing process removes the prior markings. Any excess material is permanently marked with its heat number and material type and then moved to company stock or returned to the customer as required by the purchase order Shipment of Customer Order When an order is shipped, the Shipping department will prepare: A shipping documentation package as required by the customer, Job documentation for filing into permanent storage, and Finished product for shipping, incorporating any necessary protection that ensures the receipt of a quality product by the customer Risk Management Hardy Machine's process for risk management includes: Assignment of responsibilities for risk management, Definition of risk criteria, Identification, assessment, and communication of risk throughout product realization, Identification, implementation, and management of risk actions, and

21 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 21 Acceptance of risks remaining after implementing mitigating actions Configuration Management Hardy Machine does not design and manufacture end products. There is no necessity for Hardy Machine to develop a formal configuration management system. However, customer configurations are acknowledged. Customer designated revisions and drawing changes are controlled throughout the process. Part number and revisions supplied by the customer are noted on all required documentation. Drawing revisions are reviewed for applicable changes to the product or processes. Review and or changes are noted on the fixed or frozen processes when required. Configuration Management is also a means by which identification and traceability may be maintained. In the event additional Configuration Management is required, ISO will be referenced for developing additional requirements Control of Work Transfer When planning to temporarily transfer work to a location outside the Hardy Machine's facilities, Hardy Machine will provide information via a purchase order that defines the processes to control and validate the quality of the work. 7.2 Customer-Related Processes Determination of Requirements Related to the Product Both during the quotation process and after receipt of a customer order, Hardy Machine will determine requirements related to the product. Requirements will be listed on the customer's purchase order, or will be referenced on a customer-provided bill of materials. Hardy Machine will determine: Requirements specified by the customer, including the requirements for delivery (i.e. shipping dates, packaging, etc. ) and post-delivery activities (i.e. servicing, warranty, etc.) Requirements not stated by the customer but necessary for specified and intended use where known (i.e. special processes, materials, coatings), Statutory and regulatory requirements related to the product and its use, and Any additional requirements as we determine appropriate. If the customer provides no documented statement of requirement, the customer's requirements are confirmed by Hardy Machine before acceptance. The following items will be included when determining requirements: Technical drawings Bills of Material, including raw material requirements and special processing

22 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 22 Inspection requirements Delivery date Quantity requirements Certification requirements Review of Requirements Related to the Product The General Manager, Project Manager and Shop Foreman review the requirements related to the product prior to Hardy Machine's commitment to supply a product to the customer (including before submission of tenders, before acceptance of contracts or orders, and before acceptance of changes to contracts or orders). They will ensure that: The product requirement are defined; Contract or order requirements differing from those previously expressed are resolved; Hardy Machine has the ability to meet the requirements; Special requirements of the product are determined; and Risks have been evaluated. This review will be recorded as the routing on the traveler with appropriate notes (see Section ). Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by Hardy Machine before acceptance. Where product requirements are changed, Hardy Machine shall ensure that relevant documents are amended and that relevant personnel are aware of the changed requirements. These changes will be reflected in updated travelers Quotation Processing Customer bids and Requests for Quote are processed as follows: 1. All quotations are received by any of mail, fail, , or via an online quotation service. The documents are stored electronically on the company server and indexed by customer and part number. 2. All quotation documents sent by the prospective customer are collected and reviewed for completeness. If the quotation is missing information, Hardy Machine will request the prospective customer provide that information before proceeding with the quotation. 3. The quotation requirements are reviewed and compared to Hardy Machine's in-house capabilities and to the capabilities of its suppliers to assure that we can handle the job. The decision is then made to bid the project or to decline the bid.

23 Quality Systems Manual Hardy Machine & Design Rev. 015 Page If we decide to bid the project, all requirements are defined, such as: Material requirements, Programming, New fixture development, Work center operation routings and timings, Subcontracted services, Quality requirements Packaging, and Final destination. 5. Pricing and availability of raw materials and subcontracted services are checked with approved vendors. Prices for all work centers are obtained from company standards. Overhead prices (such as setup, CNC programming, and fixture development) are added on an as-required basis. Other costs, including contingency, management costs, and profit requirements will be added to reach the final price, in accordance with Hardy Machine's standard terms and conditions of sale. 6. All quotation documentation, including client documents, quote prices, materials and outside service quotes, and worksheets will be kept electronically on the company server Customer Communication The General Manager is responsible for determining and implementing effective arrangements for communicating with customers for: Product information (through outside sales, brochures, and web sites), Inquiries, contract or order handling, including amendments (through web site, s, or faxes), Customer-planned feedback (sales reports, customer meetings, and surveys), and Unplanned feedback (customer complaints and returns). 7.3 Design and Development Excluded 7.4 Purchasing Purchasing Process The General Manager is ultimately responsible for ensuring that purchased products and services conform to Hardy Machine's specified purchasing requirements and will delegate authority as he sees

24 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 24 necessary for various purchasing functions. The type and extent of control applied to the supplier and the purchased product will be dependent upon the effect of the purchased item on finished product quality. The Project Manager will provide Hardy Machine's suppliers with the information they need to perform their services, such as drawing and specifications, upon issuing a purchase order. If the supplier informs Hardy Machine that they do not have the required information, the Project Manager will provide it. Ultimately, Hardy Machine is responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer. Subcontractors are selected based on their ability to meet contract requirements including quality system requirements and any specific quality-assurance requirements. One or more of the following methods is used to approve subcontractors: 1. Receipt and evaluation of statistical data, 2. Sampling of product during receiving inspection, 3. Second or third party assessments of subcontractor sites, 4. Evaluation by accredited laboratories. 5. The subcontractor is on a Customer Approved Subcontractor list. 6. The subcontractor receives an onsite review from Hardy Machine personnel, including completion of a Supplier Evaluation Form (Form 11). 7. Historical performance over a 1 year horizon 8. ISO approval as a basis for further performance review. If a customer has a preferred supplier, all effort will be made to utilize that preferred supplier. If a customer makes his preference known, it is assumed that the customer has already approved the supplier based on customer requirements. Hardy Machine shall: a) Maintain a dated Approved Vendors list that includes both approval status and the scope of approval. The Approved Vendors list shall also include the type and extent of control applied to the processes they supply. The following controls may be applied to vendors: i. Documentation Only Approved vendors with this control must provide documentation for their services. Generally, these vendors are controlled by third-party requirements. This control applies to Calibration labs, destructive and non-destructive vendors. ii. Dimensional Verification Approved vendors with this control will have the results of their work dimensionally checked by Hardy Machine's in-house inspectors. This control

25 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 25 applies to vendors who provide Machining services such as gundrillers, EDM, and grinding. iii. Documentation and Verification Approved vendors with this control will have their work visually and/or dimensionally checked by Hardy Machine's in-house inspectors and must provide certification as to the quality of work. This control applies to Platers and Coaters. iv. Documentation and Sampling Approved vendors with this control will have their processes confirmed by a third-party on a sampling basis. For raw material vendors and heat treat vendors, this means Hardy Machine will occasionally send a test sample to an independent lab for verification of chemical and mechanical testing. b) Periodically review supplier performance. Records of these reviews shall be used as a basis for establishing the level of controls to be implemented. Supplier performance can be reported via Syspro, which records purchase orders issued and received. c) Define the necessary actions to take when dealing with supplier that do not meet requirements. When suppliers do not meet requirements, they will be issued an NCR and will be asked to rework product to meet requirements. d) Ensure where required that both Hardy Machine and its suppliers use customer-approved special process sources; e) The General Manager and the Project Manager have the responsibility for approving supplier quality systems and have the authority to disapprove the use of sources. He shall coordinate vendor audits and review finding on a regular basis. He will also periodically review vendor NCR's and determine a supplier's approval status. f) The General Manager shall determine and manage risk when selecting and using suppliers Purchasing Information Purchasing documents (Requests for Quotations and Purchase Orders) shall describe the product or service to be purchased, including where appropriate: a) Requirements for approval of product, procedures, processes, and equipment (for example, necessary calibration procedures may be sent to a grinding vendor, or heat treatment instructions may be sent to a heat-treat vendor), b) Requirements for qualification of personnel (for example, NDT Level 3 inspector qualifications for X-Ray testing), and c) Quality System requirements for a certificate of compliance (such as API specification compliance)

26 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 26 d) The identification and revision status of specifications, drawings, process requirements, inspection instructions and other relevant technical data. e) Requirements for design, test, examination, inspection, verification (including production process verification), use of statistical techniques for product acceptance by Hardy Machine and as applicable critical items including key characteristics, f) Requirements for test specimens (e.g. production method, number, storage conditions) for design approval, inspection/verification, investigation, or auditing, g) Requirements regarding the need for the supplier to: o o o o Notify Hardy Machine of non-conforming product. Obtain Hardy Machine approval for non-conforming product disposition, Notify Hardy Machine of changes in product and/or process, changes of suppliers, change of manufacturing facility location and, where required, obtain organization approval, and Flow down to the supply chain the applicable requirements including customer requirements. h) Records retention requirements, and i) Right of access by Hardy Machine, our customers, and regulatory authorities to all areas of facilities at any level of the supply chain involved and to all applicable records. This access will be to verify the supplier's quality systems, quality of work, quality records, and material specification records. Purchasing requirements for processes directly related to product quality as listed above are maintained in the job routing during requirements review (Section 7.2.2). This allows all purchasing requirements to be automatically included on purchase orders when they are issued. Purchasing requirements are reviewed prior to communication to the vendor and personnel responsibilities for the review are identified on the purchasing documents Verification of Purchased Product Hardy Machine has established and implemented an inspection process necessary for ensuring that all purchased products and services meet specified purchase requirements and maintain precision tolerances via either inspection upon delivery from the vendor or through an assurance from a certificate of compliance. The record of this inspection process will be maintained directly on the traveler and/or the Quality Control Data Sheet (Form 1).

27 Quality Systems Manual Hardy Machine & Design Rev. 015 Page 27 The Quality Manager establishes inspection criteria that are identified on the Quality Control Data Sheet to determine the type of inspection required and the authority for release. Determining factors for inspection criteria may include: Type of product, Control exercised at the vendors' premises, and Records of performance. Inspection criteria and verification activities may include: a) Obtaining objective evidence of the, quality of the product from suppliers (such as accompanying inspection documentation, certificates of compliance, test reports, etc.) b) Inspection and audits at supplier's sites, c) Review of the required documentation, d) Inspection of products upon receipt, and e) Delegation of verification to the supplier, or supplier certification. Purchased product shall not be used or processed until it has been verified as conforming to specified requirements. Such verification shall be recorded on the traveler. When Hardy Machine utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications as listed on our purchase order. Where Hardy Machine delegates verification activities to the supplier, the requirements for delegation shall be defined on the purchase order. Where Hardy Machine's customer intends to perform verification at the vendor's premises, Hardy Machine will state the intended verification arrangements and the method of product release in the purchasing information supplied to the vendor. Where specified in the contract, the customer or customer's representative shall be afforded the right to verify at the supplier's premises and Hardy Machine's premises that subcontracted product conforms to specified requirements. Verification by the customer shall not be used by Hardy Machine as evidence of effective control of quality by the supplier and shall not absolve Hardy Machine of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.

28 Quality Systems Manual Hardy Machine & Design Rev. 015 Page Production and Service Provision Control of Production and Service Provision Hardy Machine & Design plans and carries out production and service provisions under controlled conditions. Controlled conditions include, as applicable: a) A traveler which contains or references information that describes the product, how it routes through the shop, and what raw materials are used in the product s production (See Section ), b) The availability of work instructions to personnel performing complex or critical operations, c) The use of suitable equipment, d) The availability and use of monitoring and measuring devices, e) The use of monitoring and measuring equipment, f) The implementation of release, delivery, and post-delivery activities, g) Accountability for all product during production (e.g. part quantities, split orders, nonconforming product) - see Section below for identification and traceability, h) Evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized. A signed traveler is that evidence, i) Provision for the prevention, detection, and removal of foreign body objects. The Quality Manager is charged for checking for Foreign Body Objects before packaging and shipping product, j) Monitoring and control of utilities and supplies such as water, compressed air, electricity, and chemical products to the extent they affect conformity to product requirements. The Shop Foreman is responsible for monitoring utilities, and k) Criteria for workmanship, specified in the clearest practical way. These criteria are listed on the traveler during requirements review. The Project Manager, in conjunction with the Shop Foreman, is responsible both for scheduling work centers and vendor services and for the proper operation of production processes. During requirements review (Section 7.2.2), the Project Manager plans shall include: Process controls and control plans where key characteristics have been identified, The design, manufacture, and use of tooling so that variable measurements can be taken,

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