1 Page 1 of 20 QUALITY MANUAL ISO 9001 Quality Management System Printed copies are not controlled unless marked "CONTROLLED". Upon receipt of this document, discard all previous copies.
2 Page 2 of 20 Approval Name Signature President Sean Duclos Sean Duclos Revision Record Cover Sheet Revision Date Change Description A 8/28/06 Initial Release B 1/29/07 Revise Comment on Design 7.3, Service Provision 7.5 and Scope C 9/4/08 Total revision to simplify content for readability and use D 9/1/09 Updated to ISO 9001:2008 E 10/07/11 Remove reference to ISO 9004:2000 in section 3 F 5/25/12 Added ITAR/EAR
3 Page 3 of 20 Table of Contents Table of Contents... 3 Introduction General Process Approach... 5 Figure 1: Millennium Precision Processes Interrelationship: Scope General Application and Permissible Exclusions Registration Scope: Reference Documents Terms and Definitions Quality Management System General Requirements Documentation Requirements General Quality Manual Control of Documents: Control of Records 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 General Review Input Review output Resource Management Provision of Resources Human Resources General... 13
4 Page 4 of Competency, Awareness and Training Facilities and Infrastructure Work Environment Product Realization Planning of Realization Processes Customer-Related Processes Determination of Requirements Related to the Product Review of Product Requirements Customer Communication Design and development Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Production and Service Provision Control of Production and Service Provision Validation of Processes for Production and Service Provision Identification & Traceability Customer Property Preservation of Product Control of Measuring and Monitoring Devices Measurement, Analysis, and Improvement General Measurement and Monitoring Customer Satisfaction Internal Audit Measurement and Monitoring of Processes Measurement and Monitoring of Product Control of Nonconforming Product Analysis of Data Improvement Planning for Continual Improvement Corrective Action Preventive Action... 20
5 Page 5 of 20 Introduction 0.1 General At Millennium Precision LLC we know that an inferior component can cost you money, time and credibility. In high tech manufacturing, the only tolerance is zero defects. We understand the importance of prompt quote response, quality manufacturing and on time delivery. Millennium Precision has achieved customer loyalty by practicing a policy of strong communication and working closely with customers to deliver to their exact specifications. Our investment in the best technology allows our engineering department to communicate with customers efficiently throughout the design, manufacturing and assembly processes. Millennium Precision LLC 57 Harvey Road Londonderry, NH Phone: Fax: This Quality Manual specifies requirements that Millennium Precision uses to address customer satisfaction, to meet customer and applicable regulatory and statutory requirements and to meet ISO 9001:2008, ITAR & EAR requirements, and is supported by additional procedures where necessary. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this Quality Manual. 0.2 Process Approach This Manual has adopted the process approach to quality management. Figure 1, is a conceptual illustration of the process approach of the system aimed towards Continual Improvement and illustrates the process linkages presented in clauses 4 to 8 of ISO9001. References to procedures are made as applicable or to the section of the manual that applies to that activity.
6 Page 6 of 20 Figure 1: Millennium Precision Processes Interrelationship: T o p M a n a g e m e n t Input Customer Requests Quote Purchasing 7.4 Management Rep Planning Resources 6.0 Review, Consult Appropriate Personnel and Quote Customer QM 7.2 Receive PO Incoming Inspection QA System 4.0 Quote Acceptable By Customer? Yes Resolve Nonconforming Material 8.3 Document Control Internal Audits No Review and Resolve with Customer Yes Manufacturing 7.0 Training Management Review. 5.6 CAPA Action Items or Opportunities for Improvement C u s t o m e r > > > > > Inquiry, Order, RFQ Reach Agreement? Equipment Maintenance and Calibration 7.6 Fabricate 7.0 In Process and/ or Final Inspection Yes 1 st Article Good Product No Customer Satisfaction Continuous Improvement Q&A Feedback Returns Complaints Perception Defects Order Error C u s t o m e r No Good Product No Nonconforming Material 8.3 Returns Yes Issue P/CAR 8.5.2, Yes Corrective Preventive Action ITAR Procedure P-018 is applicable throughout each process No Yes Re-entry Flow subject to disposition. Re-test required after any rework e.g. QA Inspection and/or Test CAPA as Applicable QM and Records QM Packaging, Storage or Shipping 7.5 # = Section in Quality Manual Records
7 Page 7 of 20 1 Scope 1.1 General Millennium s Quality Manual specifies requirements for a quality management system where Millennium; a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, including ITAR & EAR, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. 1.2 Application and Permissible Exclusions Exclusions against ISO 9001 apply for clause 7.3 Design and Development. Millennium Precision does not design any products. An exclusion is also taken on clause f as it relates to post delivery services. Taking the mentioned exclusions does not affect Millennium Precision s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. This manual specifies requirements for a corporate quality management system where Millennium Precision: a) Needs to demonstrate its ability to consistently provide product that meets customer requirements, and, b) Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer requirements. 1.3 Registration Scope: The Scope associated with Millennium Precision s activities and registration is: Contract Manufacturer of Swiss style machined components for industry. 2 Reference Documents ISO 9000:2005 ISO 9001:2008 Quality management systems Fundamentals and vocabulary Quality management systems Requirements 3 Terms and Definitions For the purposes of this Quality Manual, the terms and definitions given in ISO 9000 apply. Throughout the text of this Quality Manual, the term product can also mean service.
8 Page 8 of Quality Management System 4.1 General Requirements Millennium Precision established, documented and implemented a quality management system and will continually improve its effectiveness in accordance with the requirements of this Quality manual. The Quality Management System is available through Millennium Precision s electronic management system: a) identified the processes needed for the QMS and their application throughout the organization; b) determined the sequence and interaction of these processes; (see Figure 1) c) determined criteria and methods needed to ensure that both the operation and control of these processes is effective; d) ensures the availability or resources and information necessary to support the operation and monitoring of these processes; e) monitors, measures and analyzes these processes, and f) implements actions necessary to achieve planned results and continual improvement of these processes. When Millennium Precision chooses to outsource any process that affects product conformance with requirements, the organization will do so in accordance with defined requirements and methods of control to ensure effective compliance by the supplier. Such procedures may exist within the operating group or Millennium Precision s Purchasing Department quality system procedures. Processes needed for the quality management system referred to above will include processes for management activities, provision of resources, product realization and measurement. 4.2 Documentation Requirements General Millennium Precision ensures that personnel have access to quality management system documentation and are aware of relevant procedures. The quality management system documentation includes: a) documented statements of a quality policy (section 5.3 of this manual) and quality objectives (section of this manual), b) this quality manual, c) documented procedures required per ISO 9001:2008, d) documents needed to ensure the effective planning, operation and control of Millennium Precision processes, and e) records required by ISO 9001:2008 per P-002 as applicable
9 Page 9 of 20 Customer and/or regulatory authorities representatives shall have access to quality management system documentation. The extent of the quality management system documentation is to be referenced in the Documentation System and can be in any form or type of medium. The quality system structure is as follows; Quality manual - Level 1 (M-XXX) Documented procedures required by ISO 9001:2008 and as shown in the Doc-Master as well as Documents needed by Millennium Precision to ensure the effective planning, operation and control of processes - Level 2 (P-XXX) and Records required by ISO 9001:2008 Level 3 (F-XXX) as applicable. X M P F Denotes the next sequential number for each document within each level of documentation. indicates a Manual. indicates a procedure. Indicates a checklist or a Form. MP X.Y-Z may also be used to indicate the relationship to a particular clause of the standard. X being the clause, Y being the sub clause and Z indicating the next document in a sequence to that clause. Millennium Precision Quality Documentation Structure: Level 1 Quality Manual Why Philosophy / Policy Level 2 Procedures (Required documents by the standard and those needed by MP) What When Where Who How Principles / Strategy Operation / Inspection Level 3 Checklists and or Forms Forms, Checklists and documents resulting into records This manual establishes and identifies Millennium Precision s QMS requirements, processes, practices and procedures that are normally followed in the development, procurement, manufacturing, inspection and test of materials, parts and components to ensure that the products supplied are of the highest quality, consistent with existing knowledge and the current state of technology Quality Manual Millennium Precision has established and maintains this Quality Manual, (QM) to include: a) the scope of the quality management system as shown in 1.3 of this manual, including details, and justification for, any applicable exclusions described in section 1.2 of this manual; b) appropriate reference to Level 2 (P-XXX) documents in the Quality Manual; c) a brief description of the sequence and interaction of the processes included in the quality management system (see figure 1 of this manual). This Quality Manual is maintained as a controlled document and when referencing the documented procedures, the relationship between the requirements of this Manual and the documented procedures is shown.
10 Page 10 of Control of Documents: Documents required by the quality management system are controlled. Records will be controlled according to the requirements given in section of this Manual. A documented procedure (P-001) is established to define the controls needed and address how: a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose Control of Records All records are kept as described in detail in the table of Quality Records per the Quality Records Procedure (P- 002). Such records are maintained to provide evidence of conformance to the requirements and of effective operation of the quality management system. Records will remain legible, readily identifiable and retrievable. The documented procedure defines the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 5.0 Management Responsibility 5.1 Management Commitment The members of Millennium Precision s top management provide evidence of its commitment to the development and implementation of Millennium Precision s QMS and to continually improve its effectiveness by: a) communicating to the organization the importance of meeting customer, statutory and regulatory requirements; b) commitment to and deployment of the QMS Quality Policy; c) conducting management reviews at defined intervals; and d) ensuring the availability of appropriate and adequate resources. 5.2 Customer Focus Millennium Precision management ensures that customer needs and expectations are determined and that they are met with the aim of enhancing customer satisfaction as described in sections and and per procedure P-009.
11 Page 11 of Quality Policy Millennium Precision management has defined Millennium Precision s quality policy. This policy: is appropriate to the purpose of Millennium Precision; includes a commitment to meet requirements and to continually improve the effectiveness of the quality management system, provides a framework for defining, establishing, documenting and reviewing quality objectives; is communicated and understood at appropriate levels within Millennium Precision; and, is reviewed for continuing suitability. Quality Policy TO ENSURE QUALITY IS PRESENT FROM INCEPTION TO COMPLETION IN ALL THAT WE DO As a Service Driven Contract Manufacturer, Millennium Precision Provides and Continually Improves Quality-of- Product, On-Time Delivery and the Overall Service Experience While Meeting or Exceeding the Requirements and Expectations of Our Customers. Millennium Precision Commits to Review the Continued Suitability of This Policy, Promotes this Throughout the Organization, Assures Compliance with All Requirements and Continually Maintains the Effectiveness of the QMS while complying to ITAR/EAR requirements. Sean C. Duclos President 5.4 Planning Quality Objectives Millennium Precision management ensures that quality objectives, including those needed to meet requirements for product as described in section 7.1 of this manual, are established within the organization. The quality objectives are measurable and consistent with the quality policy and include the commitment to continual improvement as well as those needed to meet requirements for product Quality Management System Planning Management assures: a) The planning of the quality management system is carried out in order to meet the requirements described in paragraph 4.1 of the manual as well as the goals and objectives, and b) The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication Responsibility and authority Responsibility and authority of personnel are defined and captured by various means such as organization charts, various procedures, job descriptions, etc. as applicable to identify functions and their interrelations within Millennium Precision.
12 Page 12 of Management Representative Millennium Precision has identified and assigned a Management Representative having direct and absolute authority and responsibility for ensuring that the Quality Management System is maintained and its effectiveness is continuously improved. The management representative has been given responsibility for the Creation, Implementation, Coordination, and Auditing of the system to the ISO 9001 Standard and can be liaison with external parties on matters relating to the quality management system. The management representative is shown on the top level Organizational Chart. The management representative, irrespective of other responsibilities, has the responsibility and authority for: a) ensuring that processes of the quality management system are established and maintained; b) reporting to top management on the performance of the quality management system, including needs for improvement; c) promoting awareness of customer requirements throughout Millennium Precision, d) acting as liaison with external parties on matters relating to the quality management system. e) organizational freedom to resolve quality matters Internal Communication Millennium Precision has established and maintains processes that are communicated internally among departments regarding the QMS and its effectiveness. These processes utilize various media such as memoranda, s, electronic newsletters, meetings, teleconferences, and written or electronic reports. 5.6 Management Review General Millennium Precision s management team reviews the quality management system at least annually to ensure its continuing suitability, adequacy and effectiveness. This review evaluates any need for changes to Millennium Precision s Quality Management System, including its quality policy and quality objectives (P-007). Records from management reviews are kept (P-002) Review Input Input to management review includes current performance and improvement opportunities related to the following: a) Audit results; b) Feedback from internal and external customers; c) Process performance and product conformance; d) Status of preventive and corrective actions; e) Follow-up actions from earlier management reviews; f) Changes that could affect the quality management system. g) Recommendations for Improvement.
13 Page 13 of Review output The output from the management review is documented and includes any decisions and actions related to; a) Improvement of the effectiveness of the QMS and its processes; b) Improvement of product related to customer requirements; c) Process, product, service and/or QMS audits; d) Resource needs; e) Suitability of the Quality Policy and Objectives. 6.0 Resource Management 6.1 Provision of Resources Millennium Precision determines and provides the resources needed; a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 6.2 Human Resources General Millennium Precision personnel performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience Competency, Awareness and Training Millennium Precision: a) utilizes job descriptions to identify competency requirements for personnel performing activities effecting quality. b) provides training to satisfy these needs; c) evaluates the effectiveness of the training provided; d) ensures employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives and e) maintains appropriate records of education, experience, training, skills and experience. Millennium Precision ensures the competence of its personnel (Ref: Employee training procedure P-008). 6.3 Facilities and Infrastructure Millennium Precision determines, provides and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport or communication).
14 Page 14 of Work Environment Millennium Precision maintains its facilities to identify and manage the human and physical factors of the work environment needed to achieve product conformity, as appropriate. Millennium Precision routinely determines and manages the human and structural factors of the work environment needed to achieve conformity of product and/or service. 7.0 Product Realization 7.1 Planning of Realization Processes Millennium Precision plans and develops the processes required to achieve product realization. Planning of these realization processes is consistent with the other requirements of Millennium Precision s quality management system and is documented in forms suitable for Millennium Precision s method and areas of operation. In planning the processes for realization of product, Millennium Precision has determined the following, as appropriate: a) quality objectives for the product, project or contract; b) the need to establish processes and documentation, and provide resources and facilities specific to the product, c) verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance, d) records needed to provide confidence of conformity of the processes and resulting product. The output of this planning will be in a form suitable for Millennium Precision's method of operations. Documents specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, will be referred to as a quality plan. 7.2 Customer-Related Processes Determination of Requirements Related to the Product Millennium Precision determines customer requirements including: a) product requirements specified by the customer, including the requirements for availability, delivery and support; b) product requirements not specified by the customer but necessary for intended or specified use; c) Additional requirements related to product, including regulatory and legal requirements and as determined by Millennium Precision Review of Product Requirements Millennium Precision reviews the identified customer requirements together with any additional requirements determined. Contract review is conducted in accordance with the Customer Service Procedure (P-010) prior to the commitment to supply a product to the customer (e.g. submission of a tender, acceptance of a contract or order) and ensures that: a) product requirements are defined; b) where the customer provides no documented statement of requirement, the customer requirements are confirmed before acceptance; c) contract or order requirements differing from those previously expressed (e.g. in a tender or quotation) are resolved; d) Millennium Precision has the ability to meet defined requirements.
15 Page 15 of 20 The results of the review and subsequent follow-up actions are recorded (P-002).Where product requirements are changed, Millennium Precision ensures that relevant documentation is amended. Millennium Precision communicates any changes to relevant personnel to ensure they are made aware of the changed requirements Customer Communication Millennium Precision has determined and implemented effective arrangements for communicating with customers in relation to: a) Product information; b) Inquiries, contracts or order handling, including amendments; c) Customer feedback, including customer complaints. 7.3 Design and development 7.4 Purchasing Purchasing Process N/A See exclusion statement in section 1.2 of this manual. Millennium Precision has established purchasing processes to ensure purchased product conforms to specified requirements. Millennium Precision assures the type and extent of control applied to the supplier and is dependent upon the effect of the purchased product on subsequent product realization of the final product. (P- 011). Millennium Precision evaluates and selects suppliers based on their ability to supply product in accordance with Millennium Precision requirements. Criteria for selection, evaluation and re-evaluation, is established. Records of the results of evaluations and any necessary actions from the evaluation are maintained (P-002) Purchasing Information Purchasing documents contain information describing the product to be purchased, including where appropriate: a. requirements for approval of product, procedures, processes, and equipment b. requirements for qualification of personnel, c. quality management system requirements Verification of Purchased Product Millennium Precision has established and implemented inspection and other activities necessary for ensuring that purchased product meets specified purchase requirements. Where Millennium Precision or its customer proposes to perform verification activities at the supplier s premises, Millennium Precision may specify the intended verification arrangements and method of product release in the purchase order.
16 Page 16 of Production and Service Provision Control of Production and Service Provision Planning for control of production and service provisions, Millennium Precision considers and documents activities as listed in the electronic document control system, as appropriate. Millennium Precision controls production and service operations through: a. the availability of information that specifies the characteristics of the product; b. where necessary, the availability of work instructions; c. the use and maintenance of suitable equipment for production and service operations; d. the availability and use of measuring and monitoring devices; e. the implementation of monitoring activities; f. the implementation of defined processes for release, and delivery Post-delivery activities are excluded as mentioned in 1.2 of this manual Validation of Processes for Production and Service Provision Validation demonstrates the ability of the processes to achieve planned results. Millennium Precision validates any production and service processes where the resulting output cannot be verified by subsequent measurement or monitoring. This includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered. Millennium Precision has defined arrangements for validation that include the following, as applicable: a. qualification (review and approval) of processes, including special processes as applicable; b. qualification of equipment and personnel; c. use of defined methodologies and procedures; d. control of significant operations and parameters of special processes in accordance with process specifications and changes e. requirements for records; f. re-validation Identification & Traceability Millennium Precision identifies, where appropriate, the product by suitable means, such as routers, in-process sheets, etc. throughout product realization. Where traceability is a requirement, Millennium Precision controls and records the unique identification of the product. (P-002) Customer Property Care will be exercised while customer property is under control or being used by Millennium Precision. Millennium Precision will identify, verify, protect and maintain customer property (including intellectual property given in confidence) provided for use or incorporation into the product. Occurrence of any customer property that is lost, damaged or otherwise found to be unsuitable for use is recorded and reported to the customer immediately. A record of this report will be kept. (P-002)
17 Page 17 of Preservation of Product Millennium Precision preserves product conformity to customer requirements during internal processing and delivery to the intended destination. This includes identification, handling, packaging, storage and protection and applies to the constituent parts of a product. 7.6 Control of Measuring and Monitoring Devices Millennium Precision identifies the measurements and monitoring to be undertaken as well as the measuring and monitoring devices required to assure product conformity to specified requirements as indicated in section of this manual. The control of measuring and monitoring devices is documented in the calibration procedure, P-012. Records of calibration will be retained. (P-002). Millennium Precision maintains records of these monitoring and measuring devices, and defines the process employed for their calibration including details of equipment type, unique identification, assigned location, frequency of checks, check method and acceptance criteria. Millennium Precision established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment is: a. calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification will be recorded; b. adjusted or re-adjusted as necessary; c. identified to enable the calibration status to be determined; d. safeguarded from adjustments that would invalidate the measurement result; e. protected from damage and deterioration during handling, maintenance and storage; f. recalled to a defined method when requiring calibration. In addition, Millennium Precision assesses and records the validity of the previous measuring results when the equipment is found not to conform to requirements. Millennium Precision takes appropriate action on the equipment and any product affected. Records of calibration and verification are maintained. (P-002). When used in the monitoring and measurement of specified requirements, if applicable, the ability of computer software to satisfy the intended application will be confirmed. This will be undertaken prior to initial use and reconfirmed as necessary. 8.0 Measurement, Analysis, and Improvement 8.1 General Millennium Precision has planned and implemented the monitoring, measurement, analysis and improvement processes needed: a. to demonstrate conformity of the product, b. to ensure conformity of the quality management system, and c. to continually improve the effectiveness of the quality management system. The processes include determination of applicable methods, including statistical techniques, and the extent of their use if applicable.
18 Page 18 of Measurement and Monitoring Customer Satisfaction Millennium Precision monitors information on customer satisfaction and/or dissatisfaction as one of the measurements of performance of the quality management system. The methodologies for obtaining and using this information are described in a documented procedure. (P-009) Internal Audit Millennium Precision conducts internal audits to determine whether the quality management system conforms to the requirements of ISO 9001:2008 and those described in section 7.1 in this manual and have been effectively implemented and maintained. Internal audits are documented. (P-003). The internal audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and the methods for carrying out audits ensures objectivity and impartiality of the audit process. Auditors are always independent of the area being audited and never audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in a documented procedure. (P-005) The management responsible for the area being audited ensures that actions are taken without delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results as described in section of this manual Measurement and Monitoring of Processes Millennium Precision applies suitable methods for measurement and monitoring of those realization processes necessary to satisfy the quality management system processes. These methods confirm the continuing ability of each process to satisfy its intended purpose. In the event of process nonconformity, Millennium Precision will: a) take appropriate action to correct the process nonconformity b) evaluate whether the process nonconformity has resulted in product nonconformity c) identify and control the nonconforming product in accordance with section 8.3 herein Measurement and Monitoring of Product Millennium Precision measures and monitors the characteristics of the product to verify that requirements for the product are met. This is carried out at appropriate stages of the product realization process in accordance with planned arrangements described in section 7.1 of this manual. Evidence of conformity with the acceptance criteria is maintained. Records indicate the authority responsible for release of product. (P-002) Product release and service delivery does not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. 8.3 Control of Nonconforming Product Millennium Precision ensures that product which does not conform to requirements is identified and controlled to prevent unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in a documented procedure (P-004). Nonconforming product includes customer returns.
19 Page 19 of 20 Millennium Precision deals with nonconforming product in multiple ways, which may be any of the following: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, Millennium Precision takes action appropriate to the effects, or potential effects, of the nonconformity. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained (see P-002). 8.4 Analysis of Data Millennium Precision determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This includes data generated by measuring and monitoring activities and other relevant sources. Millennium Precision analyzes this data to provide information on: a) customer satisfaction and/or dissatisfaction; (P-009) b) conformance to product requirements; c) characteristics and trends of processes and products, including opportunities for preventive action, and, d) suppliers. 8.5 Improvement Planning for Continual Improvement Millennium Precision plans and manages the processes necessary for the continual improvement of the quality management system. Millennium Precision facilitates the continual improvement of the quality management system through the use of: a. the quality policy, b. objectives, c. audit results, d. analysis of data, e. corrective and preventive action, and f. management review Corrective Action Millennium Precision takes corrective action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective action is to be appropriate to the impact of the problems encountered. The documented procedure for corrective and preventive action is P-005, and defines requirements for: a. reviewing nonconformities (including customer complaints), b. determining the causes of nonconformities, c. evaluating the need for action to ensure that nonconformities do not recur, d. determining and implementing action needed, e. records of the results of action taken, (P-002) f. reviewing corrective action taken,
20 8.5.3 Preventive Action Number: M-001 Page 20 of 20 Millennium Precision establishes and maintains a preventive action process that takes appropriate action to determine and eliminate the causes of potential nonconformities per the Corrective and Preventive Action Procedure, P-005. This process defines requirements for: a. determining potential nonconformities and their causes, b. evaluating the need for action to prevent occurrence of nonconformities, c. determining and implementing action needed, d. records of results of action taken (P-002), and e. reviewing preventive action taken.