Transcription

Proto Technologies, Inc.AS 9100 Rev CQuality Systems Manual22808 East ApplewayLiberty Lake, WA 99019

Proto Technologies, Inc.Quality ManualIntroductionProto Technologies, Inc. developed and implemented a Quality ManagementSystem in order to document the company’s best business practices, bettersatisfy the requirements and expectations of its customers and improve theoverall management of the company.The Quality Management System of Proto Technologies, Inc. meets therequirements of the international standard SAE AS9100C. This systemaddresses the design, development and production of the company’s products.The system is suitable for post-delivery support, including the provision ofmaintenance, spare parts or materials for the company’s products.The manual is divided into eight sections that correlate to the QualityManagement System sections of the ISO 9001:2008 format and AS9100C. Eachsection begins with a policy statement expressing Proto Technologies, Inc.’sobligation to implement the basic requirements of the referenced QualityManagement System section. Each policy statement is followed by specificinformation pertaining to the procedures that describe the methods used toimplement the necessary requirements.This manual describes the Quality Management System, delineates authorities,inter relationships and responsibilities of the personnel responsible for performingwithin the system. The manual also provides procedures or references for allactivities comprising the Quality Management System to ensure compliance tothe necessary requirements of the standard.This manual is used internally to guide the company’s employees through thevarious requirements of the AS9100 Rev C standard that must be met andmaintained in order to ensure customer satisfaction, continuous improvementand provide the necessary instructions that create an empowered work force.This manual is used externally to introduce our Quality Management System toour customers and other external organizations or individuals. The manual isused to familiarize them with the controls that have been implemented and toassure them that the integrity of the Quality Management System is maintainedand focused on customer satisfaction and continuous improvement.President:QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 2 of 42

Proto Technologies, Inc.Quality ManualDocumentation SchemeILevel IQuality Manual (QM)Level IIIIDocumented ProceduresIIILevel IIIIVLevel IVWork InstructionsRecords & FormsQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 3 of 42

Proto Technologies, Inc.Quality ManualQuality Manual DistributionThe Quality Manual is distributed to the following:President,Vice President of OperationsSalesOperations ManagerQuality Manager,Management Representative,Purchasing,Production Control,Shipping Department,Receiving Department,Inventory Control,Manufacturing,Operations,Receiving Inspection,In process Inspection,Final InspectionQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 4 of 42

Proto Technologies, Inc.Quality ManualQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 5 of 42

Proto Technologies, Inc.Quality ManualSection 1: Scope1.1 GeneralScope of Quality Management System:The scope of the Quality Management System includes the production,prototyping, and manufacture of components and assemblies used in aircraft,defense department, and manufacturing industry.The quality manual outlines the policies, procedures and requirements of theQuality Management System. The system is structured to comply with theconditions set forth in the International Standard SAE AS 9100 Rev C.1.2 ApplicationProto Technologies, Inc. has determined that the following requirements are notapplicable to the operations at this site and are documented as exclusions: Identify permissible exclusions. If none, document that there are noexclusions. Document the justification for exclusions that are made.QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 6 of 42

Proto Technologies, Inc.Quality ManualSection 2: Normative Reference2.0 Quality Management System ReferencesThe following documents were used as reference during the preparation of theQuality Management System: ISO 9000:2005, Quality Management Systems - Vocabulary. ISO 9001:2008, Quality Management Systems – Requirements ISO 9004:2009, Quality Management Systems – Guidelines forPerformance Improvements SAE AS9100 Rev C (2009) - Quality Management Systems –Requirements for Aviation, Space and Defense OrganizationsQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 7 of 42

Proto Technologies, Inc.Quality ManualSection 3: Definitions3.0 Quality Management System DefinitionsReview the Terms and Definitions in ISO 9000:2005 and Clause 3 in the AS9100Cstandard and include in this section the definitions unique to Proto Technologies, Inc. Customer owned property - Any type of instrumentation, accessories,manuals, or shipping containers that belong to a customer. Customer supplied product - Any type of service or material supplied tobe utilized in the manufacture, modification or repair of customer-ownedproperty. Product – The end item result of meeting all contract terms andconditions. (eg: manufactured goods, merchandise, services etc.) Quality Records – Documentation of those activities wherein records ofsaid activities must be maintained will be specified in the procedure orwork instruction level documents, as applicable Key Characteristics- The features of a material, process, or part whosevariation has a significant influence on product fit, performance, servicelife, or manufacturability. Risk - An undesirable situation or circumstance that has both a likelihoodof occurring and a potentially negative consequence. Special requirements - Those requirements identified by the customer, ordetermined by the organization, which have high risks to being achievedthus, requiring their inclusion in the risk management process. Factorsused in the determination of special requirements include product orprocess complexity, past experience and product or process maturity. Critical items - Those items (e.g., functions, parts, software,characteristics, processes) having significant effect on the productrealization and use of the product; including safety, performance, form, fit,function, reducibility, service life, etc.; that require specific actions toensure they are adequately managed.QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 8 of 42

Proto Technologies, Inc.Quality ManualSection 4Quality ManagementSystemQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 9 of 42

Proto Technologies, Inc.Quality Manual4.1 General requirementsProto Technologies, Inc. has established, documented and implemented aQuality Management System (QMS) in accordance with the requirements ofAS9100C and statutory and regulatory requirements. The system is maintainedand continually improved through the use of the quality policy, quality objectives,audit results, analysis of data, corrective and preventive action and managementreview.To design and implement the QMS Proto Technologies, Inc. has: Determined the processes needed for the QMS and their applicationthroughout the organization and documented them on the Process FlowDiagram at the end of this section of the Quality Manual Determined the sequence and interaction of these processes, andillustrated them on the Process Flow Diagram Determined criteria and methods needed to ensure that the operation andcontrol of the processes are effective, and documented them in qualityplans, work instructions and the Measuring, Monitoring and AnalysisTable Ensured the continuing availability of resources and informationnecessary to achieve planned results and continual improvement of theseprocesses Established systems to monitor, measure and analyze these processes, Established processes to identify and implement actions necessary toachieve planned results and continual improvement of these processes, Defined the controls for outsourced processes.4.2 Documentation Requirements4.2.1 GeneralThe QMS documentation includes: A documented statements for the Quality Policy and Quality Objectives This Quality Manual Documented Procedures Documents identified as needed for the effective planning, operation andcontrol of our processes, and Quality Records Records required by statutory and regulatory authorities.QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 10 of 42

Proto Technologies, Inc.Quality ManualProto Technologies, Inc. ensures that personnel have access to qualitymanagement system documentation and are aware of relevant procedures andchanges. We also provide customer or statutory and regulatory authorities’access to quality management system documentation.4.2.2 Quality manualThis Quality Manual has been prepared to describe Proto Technologies, Inc.’sQMS. The scope and permissible exclusions of the QMS are described in sectionone of this manual. Each section of the manual references documented QMSprocedures relating to the requirements outlined in that section. The ProcessFlow Diagram at the end of section 4 provides a description of the interactionbetween the processes of the QMS system. The relationship between theAS9100C standard and documented procedure has been indicated by use of anumbering system that correlates to the AS9100 standard.4.2.3 Control of documentsAll of the QMS documents are controlled according to the Document ControlProcedure (P-423). This procedure defines the process for: Approving documents for adequacy prior to issue Reviewing and updating as necessary and re-approving documents Ensuring that changes and current revision status of documents areidentified Ensuring that relevant versions of applicable documents are available atpoints of use Ensuring that documents remain legible and readily identifiable Ensuring that documents of external origin are identified and theirdistribution controlled Preventing the unintended use of obsolete documents and to applysuitable identification to them if they are retained for any purpose.4.2.4 Control of quality recordsQuality records are maintained to provide evidence of conformity to requirementsand of the effective operation of the QMS. The records, including those createdby or maintained by suppliers, are maintained according to the Control of QualityRecords Procedure (P-424).This procedure requires that quality records remain legible, readily identifiableand retrievable. The procedure defines the controls needed for identification,storage, protection, retrieval, retention time and disposition of quality records.QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 11 of 42

Proto Technologies, Inc.Quality ManualRelated ProceduresDocument ControlP-423Control of Quality RecordsP-424QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 12 of 42

Proto Technologies, Inc.Quality ManualQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 13 of 42

Proto Technologies, Inc.Quality ManualSection 5ManagementResponsibilityQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 14 of 42

Proto Technologies, Inc.Quality Manual5.1 Management commitmentOperations Management has been actively involved in implementing the qualitymanagement system (QMS). It has provided the vision and strategic direction forthe growth of the QMS, and established quality objectives and the quality policy.Currently, Monthly Meetings are being held between the following members: Vice President of Operations Operations Manager Project Coordinator Purchasing Quality Control Manager (maintain minutes)To continue to provide leadership and show commitment to the improvement ofthe QMS, management will do the following. Communicate the importance of meeting customer, statutory, andregulatory requirements. Establish quality objectives Establish the quality policy. Conduct quarterly management reviews. Ensure the availability of resources.5.2 Customer focusProto Technologies, Inc. strives to identify current and future customer needs, tomeet customer requirements and exceed customer expectations.Operations Management ensures that product conformity and on-time deliveryperformance are measured and that appropriate action is taken if planned resultsare not achieved or will not be achieved.Operations Management ensures that customer requirements are understoodand met, by requiring compliance with documented customer communicationprocedures. Customer requirements are determined, converted into internalrequirements, and communicated to the appropriate people in our organization(P-720).QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 15 of 42

Proto Technologies, Inc.Quality Manual5.3 Quality policyOperations Management ensures that the quality policy is communicated to allemployees. It is included in new employee training and training on the QMS. It isposted in prominent places throughout the facility to maintain high standardswithin our organization.Management reviews the quality policy at each management review meeting todetermine the policy’s continuing suitability for our organization. The QualityPolicy is documented on A-500-001, Quality Policy.5.4 Planning5.4.1 Quality objectivesQuality objectives are established to support our organization’s efforts inachieving our quality policy and reviewed annually for suitability. Objectives havebeen established for the following: (Quality objectives have been established foreach division, department, and team). Quality objectives are measurable, andreviewed against performance goals at each management review meeting.(State where quality objectives have been documented. This can be stated here,in your management responsibility procedure, or in the Quality Policy documentA-500-001.)5.4.2 Quality management system planningThe quality system has been planned and implemented to meet our qualityobjectives and the requirements of 4.1 of the AS 9100 standard. Quality planningtakes place as changes that affect the quality system are planned andimplemented.5.5 Responsibility, authority and communication5.5.1 Responsibility and authorityAn organizational chart has been established to show the interrelation ofpersonnel in the organization. Job descriptions define the responsibilities andauthorities of each of the positions on the organizational chart. Job descriptionsand the organizational chart are reviewed and approved by OperationsManagement for adequacy. These documents are available throughout theorganization to help employees understand responsibilities and authorities. Anorganizational chart is located on page 5 of this manual.QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 16 of 42

Proto Technologies, Inc.Quality Manual5.5.2 Management representativeThe Operations Manager has been appointed by Vice President of Operations asmanagement representative. As management representative, they have thefollowing responsibility and authority: Ensure that processes needed for the quality management system areestablished and implemented. Report to President and VP of Operations the performance of the qualitymanagement system, and note needed improvements. Promote awareness of customer requirements throughout theorganization. Act as a liaison with external parties such as customers or auditors onmatters relating to the QMS and Resolve matters pertaining to quality issues Organizational freedom and unrestricted access to OperationsManagement to resolve matters pertaining to quality.5.5.3 Internal communicationProcesses are established for communication within the organization. Methodsof communicating the effectiveness of the QMS include department andmanagement meetings, management review, circulation of minutes ofmanagement review meetings, Internal Audit Closing meetings, and other routinebusiness communication.5.6 Management review5.6.1 GeneralOperations Management reviews the QMS quarterly at management reviewmeetings. This review assesses the continuing QMS suitability, adequacy andeffectiveness, identifying opportunities for improvement and needed changes.Records are maintained for each management review meeting.5.6.2 Review inputAssessment of the QMS is based on a review of information inputs tomanagement review. These inputs include the following: Results of audits Customer feedback Process performance and product conformity Company level quality dataQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 17 of 42

Proto Technologies, Inc.Quality Manual Status of preventive and corrective actions Follow-up actions from previous management reviews Planned changes that could affect the quality management system Recommendations for improvement5.6.3 Review outputDuring these review meetings, management will identify appropriate actions to betaken regarding the following issues: Improvement of the effectiveness of the quality management system andits processes Improvement of product related to customer requirements Resource needsResponsibility for required actions is assigned to members of the managementreview team. Any decisions made during the meeting, assigned actions, andtheir due dates are recorded in the minutes of management review.Related Procedures:Customer Related ProcessesP-720Management ResponsibilityP-500QM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 18 of 42

Proto Technologies, Inc.Quality ManualSection 6ResourceManagementQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 19 of 42

Proto Technologies, Inc.Quality Manual6.1 Provision of resourcesThe company has implemented a Quality Management System that complieswith the AS9100C standard. This implementation was achieved withmanagement commitment and with sufficient resources for the implementation.To enhance customer satisfaction and effectively maintain and continuallyimprove the system, management determines and provides necessaryresources.6.2 Human resources6.2.1 GeneralTo ensure competence of our personnel, job descriptions have been preparedidentifying the qualifications required for each position that affects productquality. Qualifications include requirements for education, skills and experience.Appropriate qualifications, along with required training, provide the competencerequired for each position.6.2.2 Competence, awareness and trainingQualifications are reviewed upon hire, when an employee changes positions orthe requirements for a position change. Quality Manager maintain records ofemployee qualifications. If any differences between the employee’s qualificationsand the requirements for the job are found, training or other action is taken toprovide the employee with the necessary competence for the job. The results arethen evaluated to ensure that the competence has been achieved. Training andevaluation are conducted according to the Training procedure. (P-622)All employees are trained on the relevance and importance of their activities andhow they contribute to the achievement of the quality objectives.6.3 InfrastructureTo meet quality objectives and product requirements Proto Technologies, Inc.has determined the infrastructure needed (P-630). The infrastructure has beenprovided, and includes buildings, workspace, utilities, process equipment andsupporting services. As new infrastructure requirements arise, they will bedocumented in quality plans. Existing infrastructure is maintained to ensureproduct conformity. Infrastructure maintenance requirements are documented in: Preventive maintenance plans Building maintenance plansQM-AS9100C Quality Manual – Rev-ADate printed 1/23/14 3:56 PMPage 20 of 42

Proto Technologies, Inc.Quality Manual6.4 Work EnvironmentA work environment suitable for achieving product conformance is maintained.Requirements are determined durin