QUALITY ASSURANCE MANUAL

Transcription

1 Marshall Precision Manufacturing Inc AL Highway 69 Guntersville, Alabama QUALITY ASSURANCE MANUAL DOCUMENT NUMBER QM-1000 REVISION: I (02/07/2018) CONTROLLED DOCUMENT Approved By: President Quality Manager

2 QM: 1000 MARSHALL PRECISION MANUFACTURING, INCORPORATED 7885 ALABAMA HIGHWAY 69 GUNTERSVILLE, AL REVISION COVER SHEET TITLE: QUALITY ASSURANCE MANUAL REVISION DATE REVISION DESCRIPTION - 12/22/98 Initial Release A 10/21/2008 Complete restructure and reformat. B 01/18/2011 Modified paragraphs 1.2, 5.2 and Added paragraph C 12/5/2011 Upgraded to AS9100 Revision C D 1/17/2013 Modified paragraphs 7.3 and E 12/8/2014 Modified paragraphs 5.5.1; ; 5.3.1; F 01/28/2015 Modified Fig 2; Par 5.2 & G 11/17/2016 Modified Fig. 5 & 6, Par. 5.2 & H 1/27/2018 Initial update to AS9100 Revision D I 02/07/2018 Completed upgrade to AS9100 Rev D

3 Quality Policy It is the policy of Marshall Precision Manufacturing Inc. to ensure customer satisfaction by: 1) Providing products and services of the highest possible standards, to satisfy our customer needs, requirements, expectations of on time delivery, product/service quality and safety. 2) Continuous improvement of our processes, products and systems; ensuring our personnel are properly trained so they are better able to serve our customers demands with inhouse zero-accident safety. Wayne Barnard, President QUALITY OBJECTIVES Keep customer rejects no more than 2% Keep on time delivery at least 98% or better Supplier on time delivery at least 98% or better FIG. 1

4 FIGURE 2 REVISION: I (02/02/2018) QUALITY MANUAL PROCEDURAL CROSS REFERENCE QUALITY MANUAL SECTION QUALITY ASSURANCE PROCEDURE 1.0 Scope QM General 1.2 Application 2.0 Normative reference QM Terms and definitions (title only) 4.0 Documented Information Maintained (title only) QP General requirements QM Documentation requirements (title only) QP Documented Information Retained QM-1000, QP Leadership (title only) 5.1 Leadership and Commitment QM-1000, QP Customer Focus QM-1000, QP Quality Policy QM-1000, Fig Planning (title only) Quality objectives QM Quality management system planning QM-1000, QP Responsibility, authority and communication (title only) Responsibility and authority QM-1000, QP Management representative QM-1000, QP Internal communication QM Management review (title only) General QM Review input QM-1000, QP Review output QM-1000, QP Resource management (title only) 6.1 Provision of resources QM-1000, QP Human resources (title only) FIGURE 2

5 FIGURE 2 REVISION: I (02/02/2018) General QM-1000, QP Competence, awareness and training QM-1000, QP Infrastructure QM Work environment QM-1000, QP Product realization (title only) 7.1 Planning of product realization QM-1000, QP-1003, QP-1009, QP Project Management QM-1000, QP Risk Management QM-1000, QP Configuration Management QM Product Safety QM-1000, QP Prevention of Counterfeit Parts 7.2 Customer-Related Processes (title only) Determination of Requirements Related to the Product QM-1000, QP Review of Requirements Related to the Product QM-1000, QP Customer Communication QM-1000, QP-1003 (Review) QP Design and Development (title only) Design and Development Planning Design and Development Inputs Design and Development Outputs Design and development Review Design and Development Verification THIS SECTION DOES NOT APPLY SEE PARAGRAPH Design and Development Validation Control of Design and Development Changes QUALITY MANUAL SECTION QUALITY ASSURANCE PROCEDURE 7.4 Control of Externally Provided Processes, Products, and Services (title only) Purchasing Process QM-1000, QP Purchasing Information QM-1000, QP Verification of Purchased Product QM-1000, QP-1006, QP Product Verification at the Suppliers Facility by the customer 7.5 Production (title only) FIGURE 2

6 FIGURE 2 REVISION: I (02/02/2018) Control of Production QM-1000, QP-1009, QP Production Documentation QM Control of Production Process Changes QM Control of Production Equipment, Tools and Software Programs QM Post-Delivery Support QM-1000, QP-1013, QP Validation of Processes for Production QM-1000, QP-1009, QP Identification and Traceability QM-1000, QP-1008, QP-1009, QP Customer and External Providers Property QM-1000, QP Preservation of Product QM-1000, QP Conformity of Product QM-1000, QP Control of monitoring and measuring devices QM-1000, QP Measurement, Analysis and Improvement (title only) 8.1 General QM-1000, QP Monitoring and Measurement (title only) Customer Satisfaction QM Internal Audit QM-1000, QP Monitoring and Measurement of Processes QM-1000, QP-1017, QP Monitoring and Measurement of Product QM-1000, QP Control of Nonconforming Product QM-1000., QP Analysis of Data QM-1000, QP Improvement (title only) Continual Improvement QM-1000, QP Corrective Action QM-1000, QP-1014 FIGURE 2

7 FIGURE 3 REVISION: I (02/02/2018) Marshall Precision Manufacturing Inc. Organizational Structure Chart President Auditing Administration Production/ Operations Quality Assurance Purchasing Contracts F I G U R E 3

8 FIGURE 4 REVISION: I (02/02/2018) Marshall Precision Manufacturing, Inc Job Descriptions Quality Manager Responsible for all aspects of quality at MPM. Competence includes work experience in quality in a fabrication machine shop understanding customer requirements, tolerances, gauges and quality engineering and systems. Responsible for the quality system at MPM, along with verifying product conforms to customer requirements. Overall responsibility for INTERNAL AUDITS, receiving inspection, first articles, product conformity, document and records control, gauge calibration, and corrective/preventive actions. President Overall responsibilities for all aspects of MPM, Inc., including providing resources to maintain the quality system and operations needed to meet customer requirements. Responsible for ensuring that management is committed to the quality system. Other responsibilities include personnel, procurement, sales, shipping and contract management. Operations Manager Responsible for all aspects of operations at MPM. Competence includes work experience in a manufacturing environment. Responsible for customer quotes, customer requirements, purchasing materials and services, customer orders, product and service costing and application of production methods and systems. Other responsibilities include assisting President and Quality Manager in their roles and responsibilities. Production Manager/Foreman Competence includes working experience of machinery in the shop, the ability to work with little or no instruction, and the ability to program operate CNC machines to run product. Responsibilities include working with the president on production scheduling of work orders on the floor. Responsible for setting up and troubleshooting machines and making product to meet specifications. Purchasing tooling, equipment, and supplies that are non-job specific. Has immediate responsibility of the operation and maintenance of the machine shop. Operators Competence in reading blue prints, working in a previous job shop or degree/certification in a machining field desired. Responsibilities include basic setup, maintenance, troubleshooting, and operation of machinery to meet part specifications. May be required to verify product conformity during processing. Operators may be required to have or obtain specific certifications depending upon the job requirements (e.g., welding certifications). Quality Technician Competence in blue print reading, gauges used in machine shop and basic shop math. Must have ability to work with very little supervision. Responsibilities include verify product to meet customer specifications, checking supplied product for conformity, and maintaining gauges on the floor stay in working order.

9 INTERNAL AUDITS (QP-1017) NONCONFORMING OUTPUTS (QP-1013) CORRECTIVE ACTION(QP-1014) MARSHALL PRECISION MANUFACTURING INC. SEQUENCE AND INTERACTION MAP TOP MANAGENMENT LEADERSHIP (QM-1000) CUSTOMER FEEDBACK (QP-1001) MANAGEMENT REVIEW & CONTINIOUS IMPROVEMENT (QP-1001) RESOURCES (QM-1000, QP-1005, QP-1011, QP-1018) CONTRACT REVIEW & PROCESS CONTROL (QP-1003, QP ) PRODUCTION & QUALITY (QP-1005, QP-1009, QP-1010, QP-1016) PURCHASING & RECEIVING INSPECTION (QP-1006, QP-1008, QP-1010) FINAL INSPECTION (QP-1009, QP-1010) PACKAGING & SHIPPING (QP-1015) DELIVERY TO THE CUSTOMER SEE QM CORE/KEY PROCESSES IDENTIFIED FOR DETAILED PROCESS IMPUTS, ACTIVITIES, OUTPUTS, MEASUREMENTS, PROCEDUAL REFERENCES, PROCESS OWNERS, CUSTOMERS/INTERESTED PARTIES, AND RISK AND OPPORTUNITIES. QM-1000 REV I, FIGURE 5

10 1.0 SCOPE The Quality Management system established by the release of this Quality Manual, along with the referenced Quality Assurance Procedures and documentation are designed to meet the requirements of ISO9001:2015, and AS9100 Rev. D. If there is a conflict between the requirements of this standard and customer or applicable statutory or regulatory requirements, the latter shall take precedence. Consistent application of the controls contained herein will support our Quality Policy. This Quality Manual is a controlled document; approved by the President and the Quality Manager and shall be reviewed at least annually as part of Management Review. This Quality Manual shall be updated as required to reflect current requirements. Uncontrolled copies of this manual may be issued to our customers and potential customers. Uncontrolled copies will not be revised. 1.1 GENERAL Marshall Precision Manufacturing, Inc. was founded in 1970, incorporated in We are a small business located in Guntersville, Alabama, occupying 16,000 feet of manufacturing floor space and 3,000 feet of office space in a primarily machine shop type environment. We are a precision manufacturing facility specializing in the production of close tolerance parts and assemblies for the aerospace and aircraft industries, government and commercial sectors. AS9100 certified in 2008 through the Alabama Boeing Supplier Development Program. The vision of MPM is to provide value added, defect free, on-time precision machining services using the resources of equipment, personnel, quality, and procedural systems and vendors. MPM will meet or exceed applicable regulatory requirements while sustaining realistic and measurable metrics indicative of value, customer satisfaction and competitive needs of target markets. Marshall Precision is a manufacturing facility providing precision machining, fabrication, and assembly of detail parts to the aerospace, defense, and commercial industries. All products are manufactured using customer furnished technical data packages, which include drawings and customer generated product specifications and acceptance criteria. The goal of Marshall Precision is to provide products and services to our aerospace and commercial customers, and satisfy other interested parties (employees, raw material and piece-part suppliers, shipping companies, and applicable regulatory or statutory entities (NASA and DCMA)). Marshall Precision consistently meets or exceeds requirements as well as all applicable regulatory and statutory requirements and work with suppliers and employees to assure quality products delivered on time. Our process-oriented Quality Management System is designed to meet the requirements of ISO9001:2015, and QM-1000 REV. I (2/7/2018) - 1 -

11 AS9100 Rev. D, and is applied to all contracts containing these or equivalent requirements. Marshall Precision management determines the processes and resources required to satisfy contract requirements during contract review and planning. This Quality Policy Manual defines the Policies, Practices and Procedures which constitute our Quality Management System which ensures consistent quality products and continual improvement. 1.2 APPLICATION The Quality system shall apply to all contracts containing the requirement for a Quality system meeting the requirements of ISO9001:2015, and AS9100 Rev: D, or equivalent. (Equivalent Quality system requirements shall be determined during contract review) When contracts are received for commercial items, management will dictate the quality arrangements and documentation requirements for that contract, production process control, and any nonconformance that might arise. Marshall Precision has determined that the following requirements are not applicable to the operations at this site and is documented as an exclusion below. Exclusions: 8.3 Design and Development of Products and Services MPM does not design or development products or services for customers. 2.0 NORMATIVE REFERENCE ISO9001:2015, Quality Management Systems: Requirements AS9100, Rev. D, Quality Management Systems Aerospace - Requirements 3.0 TERMS AND DEFINITIONS For the purpose of this manual, the terms and definitions contained in ISO 9000: 2015 apply. 4.0 DOCUMENTED INFORMATION MAINTAINED 4.1 GENERAL REQUIREMENTS Marshall Precision Mfg. Inc has established, documented, and implemented an Aerospace Quality Management System to the AS9100 Standard. Marshall Precision Mfg. Inc maintains this Quality Management System and continually QM-1000 REV. I (2/7/2018) - 2 -

12 improves its effectiveness, with the quality policy, quality objectives, audit results, analysis of process data, corrective action, and management reviews and customer reviews. Our Quality Management System has determined the processes needed for its operation and their application throughout Marshall Precision Mfg. Inc. These processes include processes for Top management, quality management system management, and sub-tier management activities, provision of resources, product realization and measurement with risk and opportunities addressed in all affected areas. Our Quality Management System has determined the sequence and the interaction of these processes. (See QM ). They are noted and shown throughout this quality manual in all sections. A reference index (Figure 2) of the documented processes, and a cross reference from the AS9100D Standard to the Quality Manual are shown in Appendix 1. Our Quality Management System has determined the criteria and methods needed to ensure that both the operation and control of these processes are effective. The processes are process based with the necessary sources of inputs, resource inputs, activities, outputs, and the receiver outputs are known and defined with overall monitoring. They are documented in form of Management Processes, Customer Processes, Support Processes, Production Processes, any applicable work instructions, customer driven quality plans and other documents. Our Quality Management System ensures the availability of resources and information necessary to support the operation and monitoring of these processes. Our Quality Management System ensures that these processes are monitored, measured where applicable, and analyzed by the Executive Management Team. Our Quality Management System ensures that necessary actions are implemented to achieve planned results and continual improvement of these processes. Marshall Precision Mfg. Inc. manages these processes as specified within this Quality Manual in accordance with the ISO 9001: 2015 and AS 9100D. Where Marshall Precision Mfg. Inc. chooses to outsource any process that affects how our products meet requirements, Marshall Precision Mfg. Inc. ensures control over such processes. Our Quality Management System identifies the type and extent of control of such outsourced processes Job Route Sheets are developed, approved and issued containing specific task requirements, product inspection and acceptance criteria and inspection points, to ensure processes (including special processes that are outsourced) are in control and are effective. (See QP-1009) Procedures have been implemented to measure, monitor and analyze information relative to the effectiveness of the quality assurance system, continuous improvement, and the initiation of corrective/preventive action as required. (See QP-1001) Procedures have been developed and implemented to control the quality of products and/or services supplied by vendors. (See QP-1006) QM-1000 REV. I (2/7/2018) - 3 -

13 4.2 DOCUMENTATION REQUIREMENTS The documented Quality Management system includes: A documented Quality Policy, Quality Objectives, Quality Assurance Manual and procedures as required by the AS 9100 standard (See. Fig 2); The required forms/records to ensure the effective planning operation and control of its processes and any applicable requirements imposed by regulatory authorities. Marshall Precision will ensure personnel have access to quality management system documentation and are aware of relevant procedures. Any customer and/or regulatory authorities representatives shall have access to quality management system documentation Marshall Precision Management has developed and issued a Quality Manual (level 1 document), reviewed and approved by Executive Management, which documents our Quality Policy, objectives and philosophy. Each requirement contained in the Quality Manual is supported by Quality Assurance Procedures (level 2 documents). These procedures define the required interaction between processes and methods used to achieve compliance to customer/contract requirements. The relationships between the various processes are contained in Core/Key Processes and Interactions diagram, and Quality Procedures. Core / Key Processes have been identified and documented (See QM ). Records, forms and tags (level 3 documents) provide objective evidence of compliance to contract/customer requirements. A forms index and a copy of Quality Assurance forms are included in attachment 1. Customer specific requirements will be added to this manual in the form of addendums Procedures have been developed and implemented to establish and define control requirements for internal and external documents requiring control. These procedures define the authority who: Ensures adequacy of documents prior to issue that includes the review of risks and opportunities to the Quality Management System (See QP-1005). Reviews and approves documents prior to release. Reviews and approves changes to documents prior to release. QM-1000 REV. I (2/7/2018) - 4 -

14 5.0 LEADERSHIP Ensures changes and current revision status of documents are identified. Ensures relevant versions of documents are available at points of use. Ensures documents are legible and readily identifiable. Ensures documents of external origin are identified and their distribution controlled and prevents the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purposes. Control of internal / external documents are contained in QP Marshall Precision will coordinate any document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements DOCUMENTED INFORMATION RETAINED Procedures have been developed and implemented to provide objective evidence (records) of conformity to contract/customer requirements and the effective operation of the quality management system. A Document Custodian has been appointed to ensure Quality records remain legible, readily identifiable and retrievable. Our Quality Assurance Procedure for control of Quality records defines requirements for identification, storage, protection, retrieval, retention times (seven years or as contractually required) and disposition. Records shall be available for review by our customers and/or regulatory agencies. (See QP-1016) 5.1 LEADERSHIP AND COMMITMENT The Top Management of Marshall Precision is committed to lead the organization toward our goal of satisfaction for our aerospace and commercial customers and other interested parties through the effective implementation of our Quality Management System. Our commitment is demonstrated by the development and publication of our Quality Policy and Objectives. (See Fig. 1) Marshall Precision conducts management reviews at regular intervals to ensure adequate resources, i.e. manpower, equipment, facilities and training are available to ensure satisfactory completion of all contract requirements. The President will promote the use of the process approach and risk-based thinking which in conjunction with the other aforementioned steps shall ensure that the Quality Management System achieves its intended results. The President assures that all personnel receive an initial orientation at the time QM-1000 REV. I (2/7/2018) - 5 -

15 of employment with an emphasis placed upon our Quality Policy, Quality objectives and Quality documentation structure. (See QP and QP-1018) 5.1 CUSTOMER FOCUS Our Quality Management system provides processes/procedures to ensure our company s focus is on understanding our customer s requirements and expectations and determining the level of our customer s satisfaction. By assessing customer satisfaction utilizing paragraph and of this document, Marshall Precision optimizes the likelihood of continually improving customer satisfaction. (See QP-1001). On-Time Delivery shall be continuously documented on the E2 Shop Management System and maintained in accordance with QP Customer Rejections shall be recorded on form 3F1013 REV. - Non-Conforming Report Log. Relevant Customer correspondence will be saved electronically. The results of this information shall be collected by the Management Team Representative and presented at each EMT meeting. (See Fig. 1 and QP-1001). 5.2 QUALITY POLICY The Quality Policy of Marshall Precision, as stated below has been developed and approved by the Marshall Precision Executive Management Team. Marshall Precision is committed to customer satisfaction through the implementation of our Quality Policy and quality objectives (see Fig. 1). Top Management assure the Quality Policy is communicated, understood, and applied within the Marshall Precision, and is made available to relevant interested parties as appropriate. 5.4 PLANNING The Executive Management Team (see paragraph 5.6.1) has developed and is responsible for the basic Quality objectives (See Figure 1). Quality objectives may be revised when approved by the Executive Management Team. Quality Performance objectives are reviewed and updated as required during the Management review meeting to ensure they address current quality needs and support the Quality Policy. QM-1000 REV. I (2/7/2018) - 6 -

16 5.4.2 Quality objectives are established at relevant functions within Marshall Precision and are measurable Quality Management System Planning The Quality Management system documented in this Quality Manual, along with the referenced Quality Assurance Procedures (QAPS) and Records constitutes the Marshall Precision Quality plan. Forms required by the implementing procedures are included in Addendum II. The Quality system elements and processes are planned to ensure that the system is suitable for its intended use and is efficient. The purpose of the Quality system is: To support the Quality policy and Objectives To ensure and demonstrate our ability to consistently produce products that meets all customer and regulatory requirements. To ensure customer satisfaction To facilitate continuous process improvement To determine and address Risks and Opportunities Marshall Precision has determined the risk and opportunities related to the quality management system in achieving its intended results through various processes to prevent or reducing undesirable effects, and to drive and achieve improvement. These processes include the review and approval process changes and additions to the quality management system (See Section 4.2.3, QP-1005); Working drawing changes meeting customer & regulatory requirements (see Section 4.2); Corrective action processing with effective closure review of actions taken to resolve nonconformities so they do not reoccur (see Section 8.5.2); customer solicitation and contract review and acceptance to assure that Marshall Precision can meet and deliver customer products on-time meeting all customer & regulatory requirements (see section 7.2); evaluate and monitor suppliers and their performance to assure they meet quality, purchasing, and delivery requirements as approved for the level of products approved for (see Section 7.4) QMS and operational risk overall is again revisited as part of management review as well as other team meetings held to discuss specific aspects of the product realization process. Changes to the Quality system and planning to reach quality objectives are conducted, approved and QM-1000 REV. I (2/7/2018) - 7 -

17 implemented by the Marshall Precision Executive Management Team. These changes may be in response to changing circumstances such as product, process, capacity, or other operational or organizational change; or to improve the effectiveness and efficiency of the Quality system. 5.5 RESPONSIBILITIES, AUTHORITY AND COMMUNICATION Responsibility and Authority The Marshall Precision organizational chart, (Fig. 5) defines the general responsibility and Authority of company management. Specific responsibility and authority are defined in the Quality Management System Procedures and in Fig. 6, Job Descriptions. The Quality Manager reports directly to the President, thereby assuring that the Quality function maintains independence from any negative influence from other departments. The Quality Manager has unrestricted access to Top Management to resolve quality management issues as noted in the Standard Section Management Representative Executive management has appointed the Quality Manager to be the Management Representative for Marshall Precision. The Management Representative irrespective of other responsibilities has responsibility and authority to: Ensure that processes comprising the Quality system are established, implemented and maintained. Report to executive management on the performance of the Quality system and improvements needed. Ensuring the promotion of awareness of customer requirements throughout the organization. (See 5.5.3) The organizational freedom to resolve matters relating to quality. Note: The Management Representative shall serve as our company liaison with external parties on matters relating to the Quality Management system. (See QP-1001) Internal Communications QM-1000 REV. I (2/7/2018) - 8 -

18 Top management ensures that there are appropriate communication processes for Marshall Precision Mfg Personnel established throughout Marshall Precision Manufacturing Inc. These communication processes will include employee training, customer communication, supplier communication, posting of quality policy and objectives, and corrective action processes. Communication of quality management system processes can include periodic companywide meetings, bulletin/story boards, Management meetings, or other means of communication by Top Management or responsible department responsible personnel. Top management further ensures that communication takes place regarding the effectiveness of our Quality Management System thru Management Review output; thru audit closing meetings and making results of internal and external audit results of our Quality Management System available throughout Marshall Precision Manufacturing applicable to personnel affected by the audit results. 5.6 MANAGEMENT REVIEW General In order to ensure the continued suitability, adequacy and effectiveness of the Quality Management system, Marshall Precision has established an Executive Management Team, consisting of the President (chairman), Quality Manager, and company personnel (as required). The management team shall perform their review at least annually. Records of all management team meetings shall be maintained, including a list of attendees Review Input Quality system performance and opportunities for improvement are determined by reviewing as a minimum the following information: (See QP-1001) Status of Actions from Previous Management Review(s) Internal / External Audit results Customer Satisfaction and Feedback (Positive and Negative) from Relevant Interested Parties Process Performance Analysis QM-1000 REV. I (2/7/2018) - 9 -

19 Product Conformity and On-time Delivery Data Performance of External Providers Status / Analysis of Nonconformities and Corrective Actions with Opportunities for Improvement Changes which could affect the Quality Management System i.e. Changing or additional customer requirements and/or expectations Recommendation for Improvement Resource requirements (Personnel, Equipment, Infrastructure) Quality Policy Relevancy, and the Extent that Quality Objectives have been Met Risk Management/Opportunities Effectiveness, with any Actions Taken Other items presented by EMT Members Review Output Corrective action items shall be documented. These items will be assigned to specific personnel with an estimated date for reporting results. Action items may include, but not be limited to: Charter Process Improvement Teams Develop Corrective/Preventive Action plans Review and update the Quality Policy and objectives Initiate requirements for special training To address Risks Identified recommend methods for improving specific processes and/or product to enhance customer satisfaction Adjust resource requirements 6.0 RESOURCE MANAGEMENT The Management Representative maintains records of management review meetings. 6.1 PROVISION OF RESOURCES Executive Management Team is responsible to: Implement and maintain the Quality Management system Continually improve the Quality Management system effectiveness Enhance customer satisfaction by meeting customer requirements. Provide all required resources. QM-1000 REV. I (2/7/2018)

20 6.2 HUMAN RESOURCES All Marshall Precision employees assigned to positions, which have an affect on product quality, must be competent to perform their tasks through education, skills, and training and experience as required (see Fig. 6). Management shall determine the requirements for training / additional skills needed for each position Organizational Knowledge, Competence, and Awareness Marshall Precision maintains Organizational Knowledge necessary for the operation and conformity of its products. This Knowledge includes both internal and external sources. Process improvements, manufacturing techniques, machining notes, experience gained from failures and successful projects. As well as outside sources such as standards, conferences, training, and knowledge from customers and external providers. Marshall Precision management monitors competence of personnel and the requirements for training/certification of personnel performing work affecting product quality and determines the requirements for additional training. A formal training review is conducted annually to ensure each employee has had all required training and to forecast additional training needs. Training programs are conducted, as required, to facilitate contract performance. Evaluations of training programs are conducted to ensure their effectiveness and personnel are made aware of the relevance and importance of their activities, what the Quality Policy is, how they contribute to the achievement of the Quality objectives, the implications of deviating from the Quality Management System, and the importance of ethical behavior. Records of training are maintained. (See QP-1018) 6.3 INFRASTRUCTURE The President with input from Department Managers as required determines the infrastructure needs for each new product, significant change to an existing product or changes required by organizational and/or business conditions. Consideration is given to the following, including maintenance: QM-1000 REV. I (2/7/2018)

21 Building Workspace Utilities Equipment Information and Communication Technology including Hardware and Software Support services 6.4 ENVIRONMENT FOR THE OPERATION OF PROCESSES The President is responsible to ensure an adequate work environment to maintain the operation of processes, achieve product conformance and mitigate unproductive human and physical factors. 7.0 PRODUCT REALIZATION The most significant of these to be considered are: Facilities Health and safety, including social, psychological, and physical conditions to help prevent human error Housekeeping Temperature humidity and lighting as required 7.1 PLANNING FOR PRODUCT REALIZATION AND DEVELOPMENT All orders are reviewed upon receipt for: Specific Quality requirements and objectives Special documentation requirements Resource requirements Product verification, validation, inspection and test requirements / criteria (See QP-1003) Records needed to provide evidence that the realization processes and resulting product meet requirements and are initiated as a result of product realization planning. Identify resources needed to support operation and maintenance of the product if needed. (See QP-1009 & QP-1010) Project Management QM-1000 REV. I (2/7/2018)

22 The President is responsible for Project Management and ensures: Project realization is planned and managed in a controlled manner. Projects meet all contract requirements at acceptable risk. Projects remain within resource and scheduled constraints Risk Management Contract risks are managed in accordance with our risk management procedure. (QP ) The process for risk management includes Assigning responsibility for risk management. Defining risk criteria. Identification, assessment, and communication of risks. Identification, implementation, and management of actions to mitigate risks. Acceptance of risks remaining after implementation of mitigating actions. Utilizing risk based thinking throughout the manufacturing process Configuration management Marshall Precision controls product configuration through ensuring: All drawings, parts lists and change orders are entered into the document control system. Current, controlled copies of drawings / change orders accompany product through the manufacturing process. Job Route Sheets reflect the latest revision of drawings. When drawings are changed, the applicable Job Route Sheet is updated, using the redline process to reflect new revisions and task requirements, if applicable (Manufacturing / inspection / test). A Master set of controlled drawings and parts lists (including changes) are maintained in the applicable contract file Product Safety Marshall Precision ensures product safety during product lifecycle by QM-1000 REV. I (2/7/2018)

23 Assessment of hazards and managing associated risks Analysis and reporting of safety related events Communication of events and training of personnel to ensure future product safety Prevention of Counterfeit Parts Marshall Precision prevents counterfeit parts from entering the supply chain by 7.2 CUSTOMER RELATED PROCESSES Utilizing customer recommended/approved suppliers Purchasing externally provided products from original manufacturer or authorized distributor Quarantine and reporting of suspect or detected counterfeit parts to customer and applicable regulatory agency Determination of Requirements Related to the Product. Marshall Precision shall determine, as needed: Customer requirements for delivery and post-delivery. Product performance requirements Statutory / regulatory requirements Any additional customer support required Any additional requirements of interested parties Review of Requirements Related to the Product Prior to a Marshall Precision commitment to supply a product to a customer, the Quality Manager, Contracts Manager, and/or the President conduct a review of product requirements. The customer supplied data package is reviewed to determine Marshall Precision ability to perform all aspects of the product requirements. In the event the customer provides no documented statement of product requirement, the Quality Manager is responsible to confirm all requirements prior to acceptance of the order. Risks are evaluated. All product requirement changes shall be routed to the Quality Manager for review. The new requirements shall be routed to the applicable Department Manager(s), who are responsible to ensure all appropriate documents are amended and that relevant personnel are aware of the change. Records of Solicitation and contract / order reviews are maintained in the applicable contract file. (See QP-1003) Customer Communication QM-1000 REV. I (2/7/2018)

24 The Quality Manager or Contracts Manager is responsible for communicating with the customer relative to contract issues, changes, handling of customer property, and contingency actions. The Quality Manager and/or Contracts Manager communicate with the customer concerning technical issues which arise during contract performance and seek resolution. Customer feedback shall be used in evaluating the need for process improvement. 7.3 DESIGNS AND DEVELOPMENT MPM Manufactures products utilizing customer furnished drawings and specifications. MPM does not perform product design. 7.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS, AND SERVICES Purchasing Process The Quality Assurance Manager shall approve a list of suppliers approved for purchases of product and services incorporated into deliverable products. The list shall include scope of the supplier s approval. Suppliers on the Approved Suppliers List shall be selected based upon their ability to supply products and / or services, which meet our product requirements. The Quality Manager is responsible to ensure a Supplier Survey Questionnaire, as deemed necessary by the Quality Manager is issued prior to placement on the Approved Suppliers List. Quality Assurance maintains records containing results of supplier surveys and / or questionnaires. Records of supplier reviews will be used as a basis for establishing the level of controls to be implemented as well as any risks identified. Suppliers performance will be reviewed at EMT meetings to determine if they are meeting all requirements and flow downs. Suppliers that do not meet requirements will be subject to actions taken by Marshall Precision. If required, Marshall Precision and its suppliers will use customer-approved special process sources, any applicable Foreign Object Detection requirement, and/or controls for the Prevention of Counterfeit parts. QM-1000 REV. I (2/7/2018)

25 The Quality Manager has the responsibility to approve supplier quality systems and also disapprove of them if they fail to meet requirements Purchasing Information Purchase Orders and all Purchase Order changes shall be reviewed and approved prior to release and shall contain a complete description of the product being ordered. The Purchasing document shall include all Quality requirements. (see QP 1006). When customer source inspection is required the requirement, shall be annotated on the Purchase document. Purchase Order changes impacting source inspection activities shall be communicated to the customer and approval obtained prior to release of the change Verification of Purchased Product Processes for verification of purchased product are dependent upon the criticality of the product and the performance history of the supplier. Records of product inspection / acceptance shall be maintained and kept by receiving inspection/quality assurance. Methods for incoming material / product verification include: Acceptance based upon product inspection Acceptance based upon an acceptable Certificate of Conformance Product Verification at the Suppliers Facility Purchased product shall not be used or processed until it has been verified as conforming to specified requirements unless it is released under positive recall procedure. Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material. Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained. QM-1000 REV. I (2/7/2018)

26 Where Marshall Precision proposes to verify the quality of products at the supplier s facility, the verification arrangements and the method of product release will be specified in the applicable purchase order Product Verification at the Suppliers Facility by the customer. 7.5 PRODUCTION The customers representative and / or regulatory agencies shall be afforded the right to verify, at the supplier s premises and / or at our premises that the supplier s product conforms to specified requirements at any time. Verification by the customer shall not be used by Marshall Precision as evidence of supplier control. Verification by the customer shall not relieve Marshall Precision of the responsibility to deliver products, which meet all customer requirements, nor shall it preclude subsequent rejection of product due to nonconformity. When customer source inspection is imposed by contract, these requirements and method of product release shall appear on the face of the purchase order. (See QP-1006) Marshall Precision has established and maintains procedures to require physical examination, measurement and / or testing of materials parts and assemblies to ensure compliance to customer requirements. When statistical process control is a contractual requirement, a contract specific statistical process control plan is developed and approved by the customer (if required) prior to implementation (See QP-1010) Control of Production Marshall Precision plans and carries out production under controlled conditions according to documented procedures. Planning considers, as applicable: The establishment of process controls and development of control plans where key characteristics have been identified, The identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization, QM-1000 REV. I (2/7/2018)

27 The design, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics, and special processes (see 7.5.2). Controlled conditions include, as applicable: The availability of information that describes the characteristics of the product The availability of work instructions The availability of resources and maintenance of work place environment to reduce human error The use of suitable equipment The availability and use of monitoring and measuring devices The implementation of monitoring and measurement The implementation of applicable product sampling plan The implementation of release, delivery and post-delivery activities accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product), part accountability to ensure bad parts have been destroyed evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized, provision for the prevention, detection, and removal of foreign objects, monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality, and criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations) Production Documentation Production operations are carried out in accordance with approved data. This data contains as necessary: Drawings, parts lists, process flow charts including inspection operations, production documents and inspection documents QM-1000 REV. I (2/7/2018)

28 A list of specific or non-specific tools and numerical control (NC) machine programs required and specific instructions associated with their use Control of Production Process Changes: Authorized people for approving changes to production processes are identified in the Process Control Procedure. Marshall Precision identifies and obtains acceptance of changes that require customer or regulatory authority approval in accordance with contract or regulatory requirements. Changes affecting processes, production equipment, tools and programs are documented, and procedures are available to control the implementation of changes. The results of changes to production processes are assessed to confirm that the desired effect has been achieved without adverse effects to product quality Control of Production Equipment, Tools and Numerical Control (N.C.) Machine Programs Production equipment, tools and programs are validated prior to use. Production equipment is maintained and inspected periodically. Validation prior to production use includes verification of the first piece produced to the design data/specification. Storage requirements, including periodic preservation/condition checks, have been established for production equipment or tooling in storage Post Delivery Support MPM provides post-delivery support for our customers as follows: Collection and analysis of in-service data when required by contract. Actions to be taken, including investigation and reporting when problems are detected after delivery shall be accomplished in accordance with QP-1014, Corrective and Preventative Action and QP-1013, QM-1000 REV. I (2/7/2018)

29 Control of Nonconforming Product. Product repair shall not be initiated without customer authorization. Control and updating of technical documentation and off-site work shall be accomplished with contract requirements Validation of Processes for Production Marshall Precision is responsible for the conformity of all externally provided processes, products, or services, including sources defined by the customer. Processes incorporated into deliverable product where the resulting output cannot be verified by monitoring or measurement and / or where deficiencies become apparent only after the product is in use are accomplished by subcontractors who appear on Marshall Precision Approved Supplier List, or the applicable Approval Suppliers List. When purchase orders are generated for these types of operations, the Purchasing documentation shall include, as applicable: (See QP-1006) Defined criteria for Marshall Precision review / approval for processes Requirements for approval of equipment and qualification of personnel Use of specific methods and procedures Documentation / records requirements Revalidation Requirements Identification and Traceability Receiving inspection inspects / verifies parts and materials upon receipt to ensure compliance to contract requirements (See QP-1010). Results of inspection activities are documented, and accepted product is identified with a Material Identification Tag (See QP-1008). All rejected material / parts are segregated and processed in accordance with our nonconforming product procedure (See QP-1013). Acceptable product is routed to designated storage areas or rooms until issued for production. Personnel retrieving material / parts from stock ensure traceability information on the material / parts match the requirements of the applicable Job Route Sheet. When unique traceability requirements are included in contracts, i.e. serial, lot / batch numbers and / or raw material accountability, the requirements are entered on the applicable Job Route Sheet. QM-1000 REV. I (2/7/2018)

30 The applicable drawings accompany the product throughout the production cycle thus ensuring product identification and traceability and inspection status throughout production and shipping operations (See QP- 1009). Quality Assurance is responsible to verify product identification / marking prior to release. Quality Assurance stamps are controlled to ensure product inspection and acceptance are performed by authorized personnel. According to the level of traceability required by contract, regulatory, or other established requirement, MPM s system provides for: Identification to be maintained throughout the product life; All the products manufactured from the same batch of raw material or from the same manufacturing batch to be traced, as well as the destination (delivery, scrap) of all products of the same batch; For an assembly, the identity of its components and those of the next higher assembly to be traced; For a given product, a sequential record of its production (manufacture, assembly, inspection) to be retrieved. MPM controls and records the unique identification of the product wherever trace-ability is a specified requirement Customer and External Providers Property Marshall Precision has developed procedures to ensure positive control of customer and external provided property used for inspection / test on material and / or equipment to be used in the manufacture or test of deliverable product (See QP-1007). Upon receipt, customer property is verified for quantity, damage during shipment, and proper certification as required. If equipment requires calibration, the equipment is entered into Marshall Precision Calibration System. Customer property is uniquely identified to distinguish it as being customer supplied. If customer supplied property is lost, damaged or otherwise found to be unsuitable for use, the Quality Manager is responsible to contact the customer for resolution. Records of these transactions shall be maintained. This also applies to property belonging to external providers, such as rented QM-1000 REV. I (2/7/2018)