AS 9100C ChecklistContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments4. Quality Management System4.1 General Requirements:Has the contractor established, documented, implemented, and maintained a Quality Management System, in accordance with the requirements of AS 9100?1Is an effective "Continuous Improvement" program, an active part of the contractor's Quality Management System?23Has the contractor:a)Identified the processes needed for the Quality Management System, including their applications throughout the contractor's organization?b)Determined the sequence and interaction of these processes?c)Determined the criteria and methods needed, to ensure that both the operation and control of these processes are effective?d)Ensured the availability of resources and information necessary, to support the operation and monitoring of these processes?e)Measured, monitored, and analyzed these processes?f)Implemented the actions necessary to achieve their planned results, including continuous improvement of the processes?4Does the contractor manage these processes, in accordance with AS 9100 requirements?Do adequate controls exist, and are they identified within the contractor's Quality Management System, for process requirements that are outsourced, and affect product conformity?5Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments4.2 Documentation Requirements:4.2.1 General:6Does the Quality Management System documentation include:a)Documented statements of a Quality policy, and Quality objectives?b)A Quality manual?c)Documented procedures required by AS 9100?d)Procedures needed by the contractor to ensure effective planning, operation, and control of the processes?e)Records required by AS 9100?Does an adequate communication process exist to ensure that personnel have access to, and are aware of, relevant Quality Management System documentation and changes?74.2.2 Quality Manual:8Has a Quality manual been established and maintained, that includes:a)The scope of the Quality Management System, including details of, and justification for any exclusions or exceptions?b)Documented procedures established for the Quality Management System, or reference to them?c)A description of the interaction between the processes of the Quality Management System?4.2.3 Control of Documents:Are the documents that are required for the Quality Management System adequately controlled?910Has a documented procedure been established, identifying the following controls:a)Approval of documents for adequacy "prior" to issue?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsb)Review and update as necessary, including re-approval of documents?10c)Ensures that changes, and the current revision status of documents are identified?d)Ensure that latest revisions, or relevant versions of applicable documents, are available at points of use?e)Ensures that documents remain legible, and are readily identifiable?f)Ensure that documents of external origin are identified, and their distribution is controlled?g)Preventing the unintended use of obsolete documents, and to apply suitable identification to them if they are retained?4.2.4 Control of Records:Have records been established and maintained to provide evidence of conformity to requirements, and of the effective operation of the Quality Management system?1112Has a documented procedure been established to define the following required controls?a)Identification?b)Storage?c)Retrieval?d)Protection?e)Retention Time?f)Disposition?Does a documented procedure exist, defining the method for controlling records that are created by, and/or retained by, suppliers?13Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments5. Management Responsibility5.1 Management Commitment:Has top management provided evidence of its commitment to the development and implementation of the Quality Management System, and for continuous improvement of its effectiveness, by:1a)Communicating to the organization the importance of meeting customer, as well as regulatory and legal requirements?b)Establishing the Quality policy?c)Ensuring that Quality objectives are established?d)Conducting Management Reviews?e)Ensuring the availability of adequate resources?5.2 Customer Focus:Has top management ensured that customer requirements are determined and met, with the aim of enhancing customer satisfaction?2Has top management established and implemented a process, to ensure that product conformity and on-time delivery are measured, and that appropriate action is taken if planned results are not, or will not, be achieved?35.3 Quality Policy:4Has top management ensured that the Quality Policy:a)Is appropriate for the purpose of the contractor's organization?b)Includes a commitment to comply with requirements, and to continually improve the effectivness of the Quality Management System?c)Provides a framework for establishing and reviewing Quality objectives?d)Is communicated and understood within the contractor's organization?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments4e)Is reviewed for continual appropriateness?5.4 Planning:5.4.1 Quality Objectives:Has top management ensured that Quality objectives are established for relevant functions, and at appropriate levels within the organization?56Have Quality objectives, needed to meet the requirements of the product, been established?7Are Quality objectives measurable, and consistant with the contractor's documented Quality Policy?5.4.2 Quality Management System Planning:Has top management ensured that the resources needed to achieve the Quality objectives are planned for, and identified?8Is the output of the contractor's planning documented? (ie; quality manual, procedures, work instructions, quality plans, etc.)9When changes to the Quality Management System are planned and implemented, does top management ensure that the integrity of the Quality System is maintained?105.5 Responsibility, Authority, and Communication:5.5.1 Responsibility and Authority:Has top management ensured that responsibilities and authorities for the Quality Management System are defined, and communicated throughout the contractor's organization?115.5.2 Management Representative:Has top management designated and appointed member(s) of management, who have reponsibility and authority that includes:12a)Ensuring that Quality processes are established, implemented, and maintained?b)Reporting to top management on the performance of the Quality Management System, including any needs for improvement?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Promoting awareness of customer requirements throughout the contractor's organization?12d)The organizational freedom, and unrestricted access to top management, to resolve Quality Management issues?5.5.3 Internal Communications:Has top management ensured that appropriate communication processes have been established throughout the organization?1314Does communication, regarding the effectiveness of the Quality Management System, take place?5.6 Management Review:5.6.1 General:Does top management accomplish "Reviews" of the Quality Management System at planned intervals, to ensure it's continuing suitability, adequacy, and effectiveness?15Are opportunities for improvement, and the need for changes to the Quality Management System, including the contractor's Quality Policy and Quality Objectives, evaluated during "Management Reviews"?1617Are records of "Management Reviews" documented and maintained as Quality records?5.6.2 Review Input:18Do the inputs to "Management Reviews" include information on:a)Results of audits?b)Customer Feedback?c)Process performance and product conformity?d)Status of preventive and corrective actions?e)Follow-up actions from previous Management Reviews?f)Planned changes that could affect the Quality Management System?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments18g)Recommendations for improvement?5.6.3 Review Output:19Do the outputs from the "Management Reviews" include the decisions and actions related to:a)Improvement of the effectiveness of the Quality Management System, and its processes?b)Improvement of the product, related to customer requirements?c)Resources that are required?6. Resource Management6.1 Provision of Resources:1Have the resources been determined and made available for:a)Implementing and maintaining a Quality Management System, including continuous improvement of it's effectiveness?b)Enhancing customer satisfaction, by meeting customer requirements?6.2 Human Resources:6.2.1 General:For personnel who perform work affecting product quality, is competency based on appropriate education, training, skills, and experience?26.2.2 Competency, Awareness, and Training:3Has the contractor's organization:a)Determined the appropriate skills and competencies, for personnel performing work affecting quality?b)Provided training, or taken other actions to satisfy competency needs?c)Evaluated the effectiveness of any actions taken?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsd)Ensured that employees are aware of the significance and importance of their activities, and how they contribute to the achievement of the Quality objectives?3e)Maintained appropriate personnel records of education, training, skills, and experience?6.3 Infrastructure:To achieve conformity of the product, does the contractor's organization identify, provide, and maintain appropriate facilities, including:4a)Buildings, workspace, and associated utilities?b)Process equipment, including hardware, and software?c)Supporting Services?6.4 Work Environment:Has the environment, needed to attain conformity of product requirements, been determined and managed adequately (noise, temperature, lighting, humidity, etc)?57. Product Realization7.1 Planning of Realization Process:Is planning of the contractor's product realization, consistent with the requirements of the other processes of the Quality Management System?12When planning product realization processes, are the following being considered and determined:a)Quality objectives, and requirements for the product, including:1) Product and personnel safety?2) Reliability, maintainability, and availability?3) Producibility and inspectability?4) Suitability of parts and materials used in the product?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments(a-Con't.)Quality objectives, and requirements for the product, including:5) Selection and development of embedded software?26) Recycling or final disposal of the product at the end of it's life?b)The need to establish processes, documents, and provide resources "specific" to the product requirements?c)Required verification, validation, monitoring, inspection, and test activities, "specific to the product", and criteria for product acceptance?d)Records that are needed, to provide evidence that the realization processes and resulting product, satisfy customer requirements?e)Configuration management appropriate to the product?f)Resources to support the use and maintenance of the product?3Is the planning output in a form, appropriate for the contractor's methods of operation?7.1.1 Project Management:Has the contractor established an adequate system, with associated processes, to plan and manage product realization in a structured and controlled manner, to meet customer requirements at an acceptable risk, within resource and schedule constraints?47.1.2 Risk Management:Has the contractor established, implemented, and maintained processes, to manage "risk" and achieve applicable customer requirements, including:5a)Assignment of responsibilities for risk management?b)Definitions of risk criteria (e.g. likelihood, consequences, risk acceptance)?c)Identification, assessment, and communication of risks throughout product realization?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsd)Identification, implementation, and management of actions, to mitigate risks that exceed the defined risk acceptance criteria?5e)Acceptance of risks remaining, after implementation of mitigating actions?7.1.3 Configuration Management:Has the contractor established, implemented, and maintained a configuration management process that includes:6a)Configuration management planning?b)Configuration identification?c)Change control processes?d)Maintaining records of configuration status?e)Configuration audits?7.1.4 Control of Work Transfers:Has the contractor established, implemented, and maintained a process, to plan and control the temporary or permanent transfer of work (e.g. from one contractor facility to another, from the contractor to a supplier, or from one supplier to another supplier), and to verify conformity of the work to the contract/customer requirements?77.2 Customer Related Processes:7.2.1 Determination of Requirements Related to the Product:8Has the contractor's organization determined:a)Requirements specified by the customer, including the requirements for delivery and post-delivery activities?b)Requirements not stated by the customer, but necessary for specified or intended use, when known?c)Statutory and regulatory requirements related to the product?d)Any additional product requirements, mandated by the contractor's Policies and/or Procedures?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.2.2 Review of Requirements Related to the Product:Prior to commitment to the customer (eg; submission of Proposals, acceptance of Contracts or Orders, or acceptance of Change Orders or Contract Modifications), are requirements reviewed to ensure that:9a)Product requirements are defined?b)Contract or Order requirements, different from those previously expressed, are resolved?c)The contractor has the ability to comply with the defined requirements?d)Any special requirements of the product are determined?e)Areas of risk have been identified (e.g. new technology, short delivery time frame, etc)?Are the results of Reviews, and actions arising from these Reviews, recorded and maintained as records?10Where the customer has not provided a documented statement of requirements, are customer requirements confirmed by the contractor, prior to acceptance?11Where product requirements are changed, does the contractor's organization ensure that applicable documentation is amended, and relevant personnel are made aware of the changed requirements?127.2.3 Customer Communication:Has the contractor's organization determined and implemented, an effective process for communicating with customers, relating to:13a)Product information and requirements?b)Inquiries, Contracts, Amendments, or Order handling?c)Customer feedback, including customer complaints?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.3 Design and Development:7.3.1 Design and Development Planning:14Are product design and development activities planned and controlled?15During design and development planning, has the contractor determined and documented:a)The various stages of design and development?b)Review, verification, and validation steps, appropriate to each design and development stage?c)Responsibilities and authorities for design and development?Has the contractor established the necessary processes to allow for the division of the design and development efforts into distinct activities, and for each activity, defined the tasks, necessary resources, responsibilities, design content, input and output data, and planning constraints?16Are the different design and development tasks to be accomplished, based on the safety and functional objectives of the product, in accordance with the customer's requirements, statutory, and regulatory requirements?17Does the contractor's process for design and development planning, take into consideration the capability to produce, inspect, test, and maintain the product?18Are interfaces managed, between the different groups that are involved in the design and development processes, to ensure effective communication, and clear assignment of responsibilities?1920Is planning output updated, as design and development progresses?7.3.2 Design and Development Inputs:21Are inputs, related to product requirements, defined, documented, and maintained?22Does design and development include:a)Functional and performance requirements?b)Applicable statutory and regulatory requirements?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsb)Applicable statutory and regulatory requirements?22c)Applicable information derived from previous similar designs?d)Other requirements that are essential for designs and development?23Are design and development inputs reviewed for adequacy?24Are incomplete, ambiguous, confusing, or conflicting requirements resolved?7.3.3 Design and Development Outputs:Are outputs of the design and development, provided in a form that enables verification against the design and development inputs?2526Are design outputs approved, prior to release?27Does the design and development output:a)Meet the design and development input requirements?b)Provide appropriate information for purchasing, production, and for a repair/service provision?c)Contain or reference product acceptance critieria?d)Specify the product characteristics that are essential to it's safe and proper use?e)Specify any critical items, if applicable, including any key characteristics, and specific actions to be accomplished for these items?Does the contractor have established processes to define the data required to allow the product to be identified, manufactured, inspected, tested, used, and maintained, including:28a)Drawings, parts lists, and specifications necessary to define the configuration and the design features of the product?b)Material, process, manufacturing, and assembly data, required to ensure conformity of the product?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.3.4 Design and Development Review:Are systematic "Reviews" (audits) performed in accordance with planned arrangements, at applicable stages in the design and development process?2930Do design and development "Reviews" (audits):a)Evaluate the capability of the design and development efforts, to comply with customer requirements?b)Identify problems, and propose necessary corrective actions?c)Authorize progression to the next stage?Do "Review" participants include representatives of functions, involved with the design and development stage(s) being reviewed?3132Are results of Reviews, and any corrective actions necessary, maintained as records?7.3.5 Design and Development Verification:Is design and development verification performed in accordance with the contractor's plan, to ensure that the design outputs, conform to the design and development input requirements?3334Are the results of verifications and corrective actions documented, and maintained as records?7.3.6 Design and Development Validation:35Is design and development validation performed in accordance with planned arrangements?Is design and development validation performed, to confirm that the product is capable of meeting the requirements of the specified application, and it's intended purpose?36Is validation completed prior to delivery, or implementation of the product, wherever applicable?3738Are the results of validation, and associated actions, maintained as records?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.3.6.1 Design and Development Verification and Validation Testing:When testing is necessary for verification and validation, are these tests planned, reviewed, controlled, and documented, to ensure and prove the following:39a)Do the test plans or specifications identify the product being tested and the resources that are to be used?1) Do they define the test objectives and conditions?2) Do they identify the test parameters that are to be recorded?3) Do they specify the relevant acceptance criteria?b)Do the test procedures describe the methods of operation, the performance of the test, and the recording of the test results?c)Are requirements specified to verify that the correct configuration of the product is being submitted for the test?d)Are there provisions specified to ensure that the requirements of the test plan and the test procedures are complied with?e)Are there provisions specified to ensure that acceptance criteria are met?7.3.6.2 Design and Development Verification and Validation Documentation:At the completion of design and/or development, does the contractor's documentation and records ensure that reports, calculations, test data, inspection results, etc, demonstrate that the product meets the specification requirements for all operational conditions?407.3.7 Control of Design and Development Changes:Are design and/or development changes identified, documented, and maintained as records?41Do reviews of design and development changes include, evaluation of the effect of the changes on associated parts, and product already delivered?42Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsAre design and development changes reviewed, verified, and validated, as appropriate, and are the changes approved, prior to implementation?4344Are results of the review of changes and required corrective actions, maintained as records?7.4 Purchasing:7.4.1 Purchasing Control:Do the Subcontracting/Purchasing processes have adequate controls in-place, to ensure that purchased products and/or services conform to the Purchase Order requirements?45Are the types of controls, and to what extent they applied to the suppliers and purchased products, evaluated and dependent upon the effect of the purchased product on subsequent product processing, or the final product?46Does the contractor have adequate controls (e.g. policies, procedures, processes, etc) in-place, to accept responsibility for the conformity of all products purchased from suppliers, including product from suppliers mandated by the customer?47Are subcontractors/suppliers evaluated and selected, based on their ability to supply product, in accordance with the contractor's requirements?48Has the contractor's organization established procedures and criteria for selection, evaluation, and re-evaluation of suppliers?4950Are results of the evaluations, and any necessary actions taken, maintained as records?51Has the contractor established a process in the Quality Management System to:a)Maintain a register of it's suppliers that includes approval status (e.g. approved, conditional, disapproved), and the scope of the approval (e.g. product type, process family, etc)?b)Periodically review supplier performance, utilizing the results of the reviews as a basis for establishing the level of controls to be implemented?c)Define the necessary actions to take, when dealing with suppliers that do not meet requirements?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsd)Ensure that when required, both the contractor and all suppliers use customer-approved special process sources?51e)Define the process, responsibilities, and authority for the approval status decision, changes of the approval status, and conditions for a controlled use of suppliers, depending on the suppliers approval status?f)Determine and manage the risk, when selecting and using suppliers?7.4.2 Purchasing Information:52Does the purchasing information describe the product to be purchased?53Do the Purchase Orders (purchasing information) to subcontractors and suppliers include:a)Requirements for approval of product, procedures, processes, and/or equipment?b)Requirements for qualification of personnel?c)Quality Management System requirements?d)The identification and revision status of specifications, drawings, process requirements, inspection/verification instructions, and other technical data?e)Requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance and related instructions for acceptance by the contractor, and if applicable, critical items, including key characteristics?53f)Requirements for test specimens (e.g. production method, number, storage conditions, etc) for design approval, inspection/verification, investigation, or auditing?g)Requirements regarding the need for the supplier/subcontractor to:1) Notify the prime contractor of nonconforming product?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsg)Requirements regarding the need for the supplier/subcontractor to:53(Con't)2) Obtain prime contractor approval for nonconforming product disposition?3) Notify the contractor of changes to the product and/or process, changes of suppliers, changes of manufacturing facility location, and when required, obtain prime contractor approval?4) Flow-down in the supply chain, applicable requirements, including customer requirements?h)Retention of records?i)"Right of access" by the contractor, the customer, and regulatory authorities, to applicable areas of "all facilities", at any level in the supply chain involved with the order, and access to "all applicable records"?54Are specified purchasing requirements evaluated for adequacy, prior to being issued to suppliers?7.4.3 Verification of Purchased Product:Has an inspection process, or other activities, been established and implemented, which are necessary for ensuring that purchased product complies with specified purchase requirements?55Has the contractor implemented an adequate process, to ensure that when purchased product is released for production use, pending completion of all required verification activities, that it is identified and recorded, to allow for recall and replacement, if it is subsequently found that the product does not meet requirements?56Does the contractor have procedures which define requirements for delegations, and require maintaining a register of delegations, for instances when the contractor chooses to delegate verification activities to the supplier?57Are verification arrangements, and/or methods of product release, specified in the purchasing information, where the contractor's organization, or it's customer, intends to perform verification at the supplier's premises?587.5 Production and Service Provision:7.5.1 Control of Production and Service Provision:Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.5.1 Control of Production and Service Provision:Are the production and service provisions planned and carried out under controlled conditions, including:59a)Availability of information that describes the product characteristics?b)Availability of work instructions (e.g. travelers, routers, manufacturing plans, inspection documents, etc)?c)Use of suitable equipment (e.g. jigs, fixtures, molds, etc)?d)Availability and use of measuring and monitoring devices?e)Implementation of monitoring and measurement?f)Implementation of release, delivery, and post-delivery activities?g)Accountability for all product during production (e.g. parts lists, parts quantities, split orders, nonconforming product, etc)?h)Evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized?i)Provisions for the prevention, detection, and removal of foreign objects?j)Monitoring and control of utilities and supplies (e.g. water, compressed air, electricity, chemical products, etc)?k)Understandable, clear criteria for workmanship (e.g. written standards, representative samples, illustrations, etc)?When planning controls for production, has the contractor considered, established, implemented, and maintained processes for:60a)Managing critical items, including process controls when key characteristics have been identified?b)Designing, manufacturing, and using tooling to measure variable data?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Identifying in-process inspection and verification points, when adequate verification of conformance cannot be performed at later stages of production/realization?60d)Special processes?7.5.1.1 Production Process Verification:61Has the contractor established and implemented a mandatory "First Article Inspection" process:a)Using a representative item from the first production run of a new part or assembly, to verify that the production processes, production documentation, and tooling, are capable of producing parts and assemblies that meet requirements?b)Incorporating provisions that the process shall be repeated, when changes occur that invalidate the original "First Article Inspection" results (e.g. engineering changes, manufacturing process changes, tooling changes, etc)?7.5.1.2 Control of Production Process Changes:Has the contractor established a method, process, and/or procedure for identification of personnel, authorized to approve changes to production processes?62Has the contractor implemented a process, to control and document changes affecting processes, production equipment, tools, or software programs?63Has the contractor developed and implemented a process, to evaluate the results of changes to production processes, assessing them to confirm that the desired effect has been accomplished, without adversely affecting product conformity?647.5.1.3 Control of Production Equipment, Tools, and Software Programs:Has the contractor implemented a process to ensure that production equipment, tools, and software programs, used to automate and control, or monitor product realization processes, are validated prior to release for production, and are maintained?65Has the contractor initiated a process, defining storage requirements, including periodic preservation and condition checks, for production equipment and/or tooling in storage?66Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.5.1.4 Post-Delivery Support:67Has the contractor established a post-delivery support process, which provides for the:a)Collection and analysis of in-service data?b)Actions to be taken, including investigation and reporting, when problems are detected after delivery?c)Control and updating of technical data?d)Approval, control, and use of repair methods?e)Controls required for off-site work (e.g. contractor's work accomplished at customer's facilities)?7.5.2 Validation of Processes for Production and Service Provision:Have processes, where deficiencies may become apparent only after the product is in use, or the service has been delivered, been validated?68Do the results of validation, demonstrate the ability of the processes to achieve the contractor's planned results?6970Has the contractor established a system and processes for:a)Defining the criteria, for the review and approval of the processes?b)Approval of equipment, and qualification of personnel?c)Use of specific methods, and/or procedures?d)Requirements for records?e)Re-validation, if required?7.5.3 Identification and Traceability:71Is the product adequately identifiable, throughout the product realization processes?Does the contractor have a process, to maintain configuration identification of the product, in order to identify any differences between the actual configuration, and the agreed-to configuration?72Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments73Is the product status identifiable, with respect to monitoring and measurement requirements?Has the contractor established a process, for control of "Acceptance Authority" media (e.g. stamps, electronic signatures, passwords, etc)?7475When traceability is a requirement, is the product uniquely identified and controlled, and:a)Is there a process to ensure that identification is maintained throughout the product life?b)Does the contractor have a process established, providing the ability to trace all products, manufactured from the same batch of raw material, or from the same manufacturing batch, to the destination (e.g. delivery, scrap, etc)?c)For an assembly, does the contractor have a process established, providing the ability to trace components to an assembly, and then to the next higher level assembly?d)For a product, does the contractor have a process established, providing the ability to retrieve a sequential record of its production (manufacture, assembly, inspection, test, etc)?76Is the product's unique identification maintained as a record?7.5.4 Customer Property:Does the contractor exercise adequate care with customer property, while it is under the organization's control, or is being used by the contractor?7778Is customer property identified, verified, protected, and safeguarded?If lost, damaged, or otherwise found to be unsuitable for use, is the condition documented, reported to the customer, and maintained as a record?797.5.5 Preservation of Product:Is conformity of product preserved during internal processing, and delivery to the intended destination?80Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments81Do the contractor's preservation activities include:a)Identification?b)Handling?c)Packaging?d)Storage?e)Protection?82Are preservation activities applied to associated component parts of a product?In accordance with product specifications, and applicable statutory and regulatory requirements, does the contractor's preservation processes include provisions for:83a)Cleaning?b)Prevention, detection, and removal of foreign objects?c)Special handling for sensitive products?d)Marking and labeling, including safety warnings?e)Shelf life control and stock rotation?f)Special handling for hazardous materials?7.6 Control of Measuring and Monitoring Devices:Has the contractor's organization determined the monitoring and measurement to take place,and the types of monitoring and measurement devices that are required, to provide evidence of conformity to requirements?84Has the contractor established and maintained a register/record of monitoring and measurement equipment that is utilized?85Has the contractor established and defined the process, employed for the calibration and verification of monitoring and measurement equipment, including details of:86a)Equipment type?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsb)Unique identification?86c)Location?d)Frequency of checks?e)Verification/check method?f)Acceptance criteria?Has the contractor identified monitoring and measurement equipment, which is used to produce inspection data to provide evidence of product conformity, as including, but not limited to:87a)Test hardware?b)Test software?c)Automated Test Equipment (ATE)?d)Plotters?e)Personally owned equipment?f)Customer supplied equipment?Have processes been established, to ensure that monitoring and measurement can be carried out, in a manner consistent with the monitoring and measurement requirements?8889Has the contractor arranged for, and ensured that existing environmental conditions are suitable for:a)Calibration?b)Inspection?c)Measurement?d)Testing?90When necessary to ensure valid results, are measuring equipment:a)Calibrated or verified at specific intervals, or prior to use, against measurement standards that are traceable to international or national measurement standards; where no standard exists, is the foundation used for calibration or verification recorded?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsb)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 results?e)Protected from damage and deterioration during handling, maintenance, and storage?Has the contractor established, implemented, and maintained a process, for the recall of monitoring and measurement equipment requiring calibration or verification?91Has the contractor evaluated and recorded the validity of previous measuring results, when the equipment is found not to conform to the requirements, and have they taken the appropriate corrective action on the equipment, and any affected product?9293Are records of calibration and verification results maintained?When computer software is used in the monitoring and measurement of specified requirements, is the ability of the computer software to satisfy the intended purpose confirmed, prior to use?94Does the contractor's process, for confirmation of computer software to satisfy it's intended purpose, include verification and configuration management to maintain it's suitability for use?9596Is the ability of computer software, to satisfy the intended application, reconfirmed as needed?8. Measurement, Analysis, and Improvement8.1 General:Have the monitoring, measurement, analysis, and improvement processes been planned, documented, and implemented to:1a)Demonstrate conformity of the product?b)Ensure conformity of the Quality Management System?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments1c)Continually improve the effectiveness of the Quality Management System?Have applicable process methods, including statistical techniques, and their extent of use, been determined?23Does the contractor use statistical techniques to support:a)Design verification (e.g. reliability, mantainability, safety, etc)?b)Process controls, including:1)Selection and inspection of key characteristics?2)Process capability measurements?3)Statistical process control?4)Design of experiments?c)Inspection?d)Failure mode, effect, and criticality analysis?8.2 Monitoring and Measurement:8.2.1 Customer Satisfaction:Is information and data, relating to customer perception, monitored by the contractor, as to whether customer requirements have been met?4Have the methodologies for obtaining and using information and data, related to customer perception, been determined?5Is the information that the contractor monitors and uses for evaluation of customer satisfaction include, but not limited to:6a)Product conformity?b)On-time delivery performance?c)Customer complaints?d)Corrective action requests?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsHas the contractor developed and implemented plans for customer satisfaction improvement, addressing deficiencies identified by these evaluations, and assessing the effectiveness of the results?78.2.2 Internal Audits:Are internal audits conducted at planned intervals, to determine whether the Quality Management System:8a)Conforms to planned arrangements, requirements of ISO 9001, customer contractual requirements, and the Quality Management System?b)Is effectively implemented and maintained?When planning audits, does the contractor take into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits?910Are audit criteria, scope, frequency, and methods defined?Is auditor selection considered by the contractor, to ensure objectivity and impartiality of the audit process?1112Do controls exist to ensure that auditors do not audit their own work?Has a documented procedure been established to define the responsibilities, requirements for planning and conducting audits, reporting results, and maintaining records?13Has management, which is responsible for the area(s) being audited, ensured that corrective actions have been initiated without delay, to eliminate detected nonconformities, and their root causes?14Do follow-up activities include verification of the corrective actions taken, and the reporting of the verification results?158.2.3 Monitoring and Measurement of Processes:Are appropriate methods applied for monitoring, and where applicable, measurement of the Quality Management System processes, that are required to meet customer requirements?16Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments17Do these methods demonstrate the ability of the processes to achieve the planned results?18Are corrective actions implemented, when planned results are not achieved?In the event of process nonconformity, has the contractor established and implemented a process and controls to:19a)Take appropriate action to correct the nonconforming process?b)Evaluate whether the process nonconformity has resulted in product nonconformities?c)Determine if the process nonconformity is limited to a specific case, or whether it could have affected other processes or products?d)Identify and control any nonconforming product?8.2.4 Monitoring and Measurement of Product:Are product characteristics monitored and measured, to verify that product requirements are met?20Is monitoring and measurement of product characteristics, implemented at appropriate stages of the product realization process, in accordance with the contractor's plans?2122Is evidence of conformity with the acceptance criteria, documented and maintained?Has the contractor established the process, and documented measurement requirements for product acceptance, including:23a)Criteria for acceptance and/or rejection?b)Where in the manufacturing sequence, measurement and testing are to be performed?c)Required records of the measurement results (e.g. at a minimum, indication of acceptance or rejection)?d)Any unique or specific measurement instruments required, and any specific instructions associated with their use?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsWhen critical items, including any key characteristics have been identified, does the contractor ensure they are controlled and monitored, in accordance with established processes?24When the contractor has decided to use "Sampling Inspection" as a means of product acceptance, has the sampling plan been justified on the basis of recognized statistical principles, and is it appropriate for use (e.g. matching the sampling plan to the criticality of the product, and to process capability)?25Does the contractor have a documented process established, so that when product is released for further processing and production use, pending completion of all required measurement, inspection, testing, and monitoring activities, is it adequately identified and recorded to allow for recall and replacement, if it is subsequently found that the product does not meet requirements?2627Are records maintained that indicate the person(s) authorizing release of product?When required to demonstrate product qualification, does the contractor have an established process, to ensure that records provide evidence that the product meets the defined requirements?28Unless otherwise approved by a relevant authority, or where applicable, the customer, are all planned processes satisfactorily completed, prior to proceeding with release of the product?29Does the contractor have an established process, to ensure that all documents that are required to accompany the product, are present at delivery?308.3 Control of Nonconforming Product:31Is nonconforming product identified and controlled, to prevent unintended use or delivery?Has a documented procedure been established to define process controls, identify authorities and their related responsibilities, for dealing with nonconforming product?32Do the contractor's procedures define nonconforming product, as including nonconforming product returned by the customer?33Does the contractor's documented procedure(s) define the responsibility, and authority, for the review and disposition of nonconforming product, and explain the process for approving personnel making these decisions?34Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments35Is the process for dealing with nonconforming product, one or more of the following ways:a)Is action taken to eliminate the detected nonconformity?b)Nonconforming product is authorized for use, release, or acceptance, by approval of a relevant authority, and when applicable, by the customer?c)Is adequate action taken, to prevent using the nonconforming product for it's original intended use or application?d)When nonconforming product is detected after delivery, or use has started, is appropriate evaluation and corrective action taken by the contractor, to analyze the effect, or potential effect, the nonconformity may have on other component parts, and/or Systems?e)Does the contractor take the necessary actions, to contain and/or limit the potential effects of the nonconformity, on other processes or products?Does the contractor's process for control of nonconforming product, provide for timely reporting of delivered nonconforming product?36Does the contractor have a process established, for notification of parties concerning nonconforming product, including notification to applicable suppliers, internal organizations, customers, distributors, and regulatory authorities?37Does the contractor's process procedures for control of nonconforming material, specify that dispositions of "use-as-is" or "repair", shall only be used, after approval by an authorized representative, or personnel having delegated authority, from the organization responsible for design?38If the nonconformity results in a departure from the contract requirements, does the contractor have provisions in their control of nonconforming material process, to prevent the use of "use-as-is" and "repair" dispositions, unless specifically authorized by the customer?39Does the contractor's control of nonconforming material process procedure(s), specify that product dispositioned for "scrap", shall be conspicuously and permanently marked, or positively controlled, until physically rendered unusable?40Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsAre adequate records maintained, identifying the nature of nonconformities, and any subsequent corrective actions taken, including any waivers, deviations, or authorized concessions?41When nonconforming product is corrected, is it subject to re-verification, to demonstrate conformity to the requirements?428.4 Analysis of Data:Is appropriate data determined, collected, and analyzed, to demonstrate the suitability and effectiveness of the Quality Management System, and to evaluate where continuous improvement of the effectiveness of the Quality Management System can be made?43Does this data include data generated from monitoring , measurement, and other relevant sources?4445Does the contractor's analysis of data, provide information related to:a)Customer satisfaction?b)Conformance to product requirements?c)Characteristics and trends, of products and processes, including opportunities for preventive action?d)Adequacy of suppliers/subcontractors?8.5 Process Improvement:8.5.1 Continual Improvement:Does the contractor have procedure(s) and a process established, to promote continual improvement of the effectiveness of the Quality Management System?46Are the results of audits, analysis of data, corrective and preventive actions, Management Reviews, Quality Policy, and Quality Objectives, used for continual improvement?47Does the contractor have a process established, to monitor the implementation of improvement activities, resulting from activities such as "lessons learned", "problem resolutions", and the "benchmarking of best practices", and evaluate the effectiveness of the results?48Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments8.5.2 Corrective Action:Are corrective actions taken to eliminate the root cause(s) of nonconformities, and to prevent recurrence?4950Are corrective actions appropriate to eliminate the effects of the nonconformities encountered?51Has a documented procedure been established, to define the requirements for:a)Reviewing nonconformities, including customer complaints?b)Determining the root cause(s) of nonconformities?c)Evaluating the need for corrective action(s), to ensure that nonconformities do not recur?d)Determining and implementing adequate corrective action(s)?e)Recording and maintaining the results of corrective actions taken?f)Reviewing corrective actions?g)Flowing down corrective action requirements to a supplier, when it is determined that the supplier is responsible for the nonconformity?h)Specific actions, when timely and/or effective corrective actions are not achieved?i)Determining if additional nonconforming product exists, based on the causes of the nonconformities, and taking further action, when required?8.5.3 Preventive Action:Has the contractor's organization initiated adequate corrective actions, to eliminate the root causes of potential nonconformities, in order to prevent reoccurrence?52Are preventive action opportunities, such as "risk management", "error proofing", " failure mode and effect analysis (FMEA)", and "information on product problems reported by external sources", utilized appropriately to control and/or eliminate effects of potential problems?53Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments54Has a documented procedure been established, to define the requirements for:a)Determining potential nonconformities and their root causes?b)Evaluating the need for preventive action, to preclude reoccurrence of nonconformities?c)Determining and implementing corrective and preventive actions that are needed?d)Recording and maintaining the results of preventive actions taken?e)Review of preventive actions taken?Notes & CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:Notes & Comments

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AS9100 Ch. 4 General Reqmn'tsContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments4. Quality Management System4.1 General Requirements:Has the contractor established, documented, implemented, and maintained a Quality Management System, in accordance with the requirements of AS 9100?1Is an effective "Continuous Improvement" program, an active part of the contractor's Quality Management System?23Has the contractor:a)Identified the processes needed for the Quality Management System, including their applications throughout the contractor's organization?b)Determined the sequence and interaction of these processes?c)Determined the criteria and methods needed, to ensure that both the operation and control of these processes are effective?d)Ensured the availability of resources and information necessary, to support the operation and monitoring of these processes?e)Measured, monitored, and analyzed these processes?f)Implemented the actions necessary to achieve their planned results, including continuous improvement of the processes?4Does the contractor manage these processes, in accordance with AS 9100 requirements?Do adequate controls exist, and are they identified within the contractor's Quality Management System, for process requirements that are outsourced and affect product conformity?54.2 Documentation Requirements:4.2.1 General:6Does the Quality Management System documentation include:a)Documented statements of a Quality policy, and Quality objectives?b)A Quality manual?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Documented procedures required by AS 9100?6d)Procedures needed by the contractor to ensure the effective planning, operation, and control of the processes?e)Records required by AS 9100?Does an adequate communication process exist to ensure that personnel have access to, and are aware of, relevant Quality Management System documentation and changes?74.2.2 Quality Manual:8Has a Quality manual been established and maintained, that includes:a)The scope of the Quality Management System, including details of, and justification for any exclusions or exceptions?b)Documented procedures established for the Quality Management System, or reference to them?c)A description of the interaction between the processes of the Quality Management System?4.2.3 Control of Documents:Are the documents that are required for the Quality Management System adequately controlled?910Has a documented procedure been established, identifying the following controls:a)Approval of documents for adequacy "prior" to issue?b)Review and update as necessary, including re-approval of documents?c)Ensures that changes, and the current revision status of documents are identified?d)Ensure that latest revisions, or relevant versions of applicable documents, are available at points of use?e)Ensures that documents remain legible, and are readily identifiable?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsf)Ensure that documents of external origin are identified, and their distribution is controlled?10g)Preventing the unintended use of obsolete documents, and to apply suitable identification to them if they are retained?4.2.4 Control of Records:Have records been established and maintained to provide evidence of conformity to requirements, and of the effective operation of the Quality Management system?1112Has a documented procedure been established to define the following required controls?a)Identification?b)Storage?c)Retrieval?d)Protection?e)Retention Time?f)Disposition?Does a documented procedure exist, defining the method for controlling records that are created by, and/or retained by, suppliers?13Notes & CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:Notes & Comments

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AS9100 Ch. 5 Mgm't SystemsContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments5. Management Responsibility5.1 Management Commitment:Has top management provided evidence of its commitment to the development and implementation of the Quality Management System, and for continuous improvement of its effectiveness, by:1a)Communicating to the organization the importance of meeting customer, as well as regulatory and legal requirements?b)Establishing the Quality policy?c)Ensuring that Quality objectives are established?d)Conducting Management Reviews?e)Ensuring the availability of adequate resources?5.2 Customer Focus:Has top management ensured that customer requirements are determined and met, with the aim of enhancing customer satisfaction?2Has top management established and implemented a process, to ensure that product conformity and on-time delivery are measured, and that appropriate action is taken if planned results are not, or will not, be achieved?35.3 Quality Policy:4Has top management ensured that the Quality Policy:a)Is appropriate for the purpose of the contractor's organization?b)Includes a commitment to comply with requirements, and to continually improve the effectivness of the Quality Management System?c)Provides a framework for establishing and reviewing Quality objectives?d)Is communicated and understood within the contractor's organization?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments4e)Is reviewed for continual appropriateness?5.4 Planning:5.4.1 Quality Objectives:Has top management ensured that Quality objectives are established for relevant functions, and at appropriate levels within the organization?56Have Quality objectives, needed to meet the requirements of the product, been established?7Are Quality objectives measurable, and consistant with the contractor's documented Quality Policy?5.4.2 Quality Management System Planning:Has top management ensured that the resources needed to achieve the Quality objectives are planned for, and identified?8Is the output of the contractor's planning documented? (ie; quality manual, procedures, work instructions, quality plans, etc.)9When changes to the Quality Management System are planned and implemented, does top management ensure that the integrity of the Quality System is maintained?105.5 Responsibility, Authority, and Communication:5.5.1 Responsibility and Authority:Has top management ensured that responsibilities and authorities for the Quality Management System are defined, and communicated throughout the contractor's organization?115.5.2 Management Representative:Has top management designated and appointed member(s) of management, who have reponsibility and authority that includes:12a)Ensuring that Quality processes are established, implemented, and maintained?b)Reporting to top management on the performance of the Quality Management System, including any needs for improvement?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Promoting awareness of customer requirements throughout the contractor's organization?12d)The organizational freedom, and unrestricted access to top management, to resolve Quality Management issues?5.5.3 Internal Communications:Has top management ensured that appropriate communication processes have been established throughout the organization?1314Does communication, regarding the effectiveness of the Quality Management System, take place?5.6 Management Review:5.6.1 General:Does top management accomplish "Reviews" of the Quality Management System at planned intervals, to ensure it's continuing suitability, adequacy, and effectiveness?15Are opportunities for improvement, and the need for changes to the Quality Management System, including the contractor's Quality Policy and Quality Objectives, evaluated during "Management Reviews"?1617Are records of "Management Reviews" documented and maintained as Quality records?5.6.2 Review Input:18Do the inputs to "Management Reviews" include information on:a)Results of audits?b)Customer Feedback?c)Process performance and product conformity?d)Status of preventive and corrective actions?e)Follow-up actions from previous Management Reviews?f)Planned changes that could affect the Quality Management System?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments18g)Recommendations for improvement?5.6.3 Review Output:19Do the outputs from the "Management Reviews" include the decisions and actions related to:a)Improvement of the effectiveness of the Quality Management System, and its processes?b)Improvement of the product, related to customer requirements?c)Resources that are required?Notes & CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:Notes & Comments

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AS9100 Ch. 6 Resource Mgm't Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments6. Resource Management6.1 Provision of Resources:1Have the resources been determined and made available for:a)Implementing and maintaining a Quality Management System, including continuous improvement of it's effectiveness?b)Enhancing customer satisfaction, by meeting customer requirements?6.2 Human Resources:6.2.1 General:For personnel who perform work affecting product quality, is competency based on appropriate education, training, skills, and experience?26.2.2 Competency, Awareness, and Training:3Has the contractor's organization:a)Determined the appropriate skills and competencies, for personnel performing work affecting quality?b)Provided training, or taken other actions to satisfy competency needs?c)Evaluated the effectiveness of any actions taken?d)Ensured that employees are aware of the significance and importance of their activities, and how they contribute to the achievement of the Quality objectives?e)Maintained appropriate personnel records of education, training, skills, and experience?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments6.3 Infrastructure:To achieve conformity of the product, does the contractor's organization identify, provide, and maintain appropriate facilities, including:4a)Buildings, workspace, and associated utilities?b)Process equipment, including hardware, and software?c)Supporting Services?6.4 Work Environment:Has the environment, needed to attain conformity of product requirements, been determined and managed adequately (noise, temperature, lighting, humidity, etc)?5Notes & CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:Notes & Comments

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AS9100 Ch.7 Product & SuppliersContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7. Product Realization7.1 Planning of Realization Process:Is planning of the contractor's product realization, consistent with the requirements of the other processes of the Quality Management System?12When planning product realization processes, are the following being considered and determined:a)Quality objectives, and requirements for the product, including:1) Product and personnel safety?2) Reliability, maintainability, and availability?3) Producibility and inspectability?4) Suitability of parts and materials used in the product?5) Selection and development of embedded software?6) Recycling or final disposal of the product at the end of it's life?b)The need to establish processes, documents, and provide resources "specific" to the product requirements?c)Required verification, validation, monitoring, inspection, and test activities, "specific to the product", and criteria for product acceptance?d)Records that are needed, to provide evidence that the realization processes and resulting product, satisfy customer requirements?e)Configuration management appropriate to the product?f)Resources to support the use and maintenance of the product?3Is the planning output in a form, appropriate for the contractor's methods of operation?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.1.1 Project Management:Has the contractor established an adequate system, with associated processes, to plan and manage product realization in a structured and controlled manner, to meet customer requirements at an acceptable risk, within resource and schedule constraints?47.1.2 Risk Management:Has the contractor established, implemented, and maintained processes, to manage "risk" and achieve applicable customer requirements, including:5a)Assignment of responsibilities for risk management?b)Definitions of risk criteria (e.g. likelihood, consequences, risk acceptance)?c)Identification, assessment, and communication of risks throughout product realization?d)Identification, implementation, and management of actions, to mitigate risks that exceed the defined risk acceptance criteria?e)Acceptance of risks remaining, after implementation of mitigating actions?7.1.3 Configuration Management:Has the contractor established, implemented, and maintained a configuration management process that includes:6a)Configuration management planning?b)Configuration identification?c)Change control processes?d)Maintaining records of configuration status?e)Configuration audits?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments7.1.4 Control of Work Transfers:Has the contractor established, implemented, and maintained a process, to plan and control the temporary or permanent transfer of work (e.g. from one contractor facility to another, from the contractor to a supplier, or from one supplier to another supplier), and to verify conformity of the work to the contract/customer requirements?77.2 Customer Related Processes:7.2.1 Determination of Requirements Related to the Product:8Has the contractor's organization determined:a)Requirements specified by the customer, including the requirements for delivery and post-delivery activities?b)Requirements not stated by the customer, but necessary for specified or intended use, when known?c)Statutory and regulatory requirements related to the product?d)Any additional product requirements, mandated by the contractor's Policies and/or Procedures?7.2.2 Review of Requirements Related to the Product:Prior to commitment to the customer (eg; submission of Proposals, acceptance of Contracts or Orders, or acceptance of Change Orders or Contract Modifications), are requirements reviewed to ensure that:9a)Product requirements are defined?b)Contract or Order requirements, different from those previously expressed, are resolved?c)The contractor has the ability to comply with the defined requirements?d)Any special requirements of the product are determined?e)Areas of risk have been identified (e.g. new technology, short delivery time frame, etc)?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsAre the results of Reviews, and actions arising from these Reviews, recorded and maintained as records?10Where the customer has not provided a documented statement of requirements, are customer requirements confirmed by the contractor, prior to acceptance?11Where product requirements are changed, does the contractor's organization ensure that appropriate documentation is amended, and relevant personnel are made aware of the changed requirements?127.2.3 Customer Communication:Has the contractor's organization determined and implemented, an effective process for communicating with customers, relating to:13a)Product information and requirements?b)Inquiries, Contracts, Amendments, or Order handling?c)Customer feedback, including customer complaints?7.3 Design and Development:7.3.1 Design and Development Planning:14Are product design and development activities planned and controlled?15During design and development planning, has the contractor determined and documented:a)The various stages of design and development?b)Review, verification, and validation steps, appropriate to each design and development stage?c)Responsibilities and authorities for design and development?Has the contractor established the necessary processes to allow for the division of the design and development efforts into distinct activities, and for each activity, defined the tasks, necessary resources, responsibilities, design content, input and output data, and planning constraints?16Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsAre the different design and development tasks to be accomplished, based on the safety and functional objectives of the product, in accordance with the customer's requirements, statutory, and regulatory requirements?17Does the contractor's process for design and development planning, take into consideration the capability to produce, inspect, test, and maintain the product?18Are interfaces managed, between the different groups that are involved in the design and development processes, to ensure effective communication, and clear assignment of responsibilities?1920Is planning output updated, as design and development progresses?7.3.2 Design and Development Inputs:21Are inputs, related to product requirements, defined, documented, and maintained?22Does design and development include:a)Functional and performance requirements?b)Applicable statutory and regulatory requirements?c)Applicable information derived from previous similar designs?d)Other requirements that are essential for designs and development?23Are design and development inputs reviewed for adequacy?24Are incomplete, ambiguous, confusing, or conflicting requirements resolved?7.3.3 Design and Development Outputs:Are outputs of the design and development, provided in a form that enables verification against the design and development inputs?2526Are design outputs approved, prior to release?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments27Does the design and development output:a)Meet the design and development input requirements?b)Provide appropriate information for purchasing, production, and for a repair/service provision?c)Contain or reference product acceptance critieria?d)Specify the product characteristics that are essential to it's safe and proper use?e)Specify any critical items, if applicable, including any key characteristics, and specific actions to be accomplished for these items?Does the contractor have established processes to define the data required to allow the product to be identified, manufactured, inspected, tested, used, and maintained, including:28a)Drawings, parts lists, and specifications necessary to define the configuration and the design features of the product?b)Material, process, manufacturing, and assembly data, required to ensure conformity of the product?7.3.4 Design and Development Review:Are systematic "Reviews" (audits) performed in accordance with planned arrangements, at applicable stages in the design and development process?2930Do design and development "Reviews" (audits):a)Evaluate the capability of the design and development efforts, to comply with customer requirements?b)Identify problems, and propose necessary corrective actions?c)Authorize progression to the next stage?Do "Review" participants include representatives of functions, involved with the design and development stage(s) being reviewed?31Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments32Are results of "Reviews", and any corrective actions necessary, maintained as records?7.3.5 Design and Development Verification:Is design and development verification performed in accordance with the contractor's plan, to ensure that the design outputs, conform to the design and development input requirements?3334Are the results of verifications and corrective actions documented, and maintained as records?7.3.6 Design and Development Validation:35Is design and development validation performed in accordance with planned arrangements?Is design and development validation performed, to confirm that the product is capable of meeting the requirements of the specified application, and it's intended purpose?36Is validation completed prior to delivery, or implementation of the product, wherever applicable?3738Are the results of validation, and associated actions, maintained as records?7.3.6.1 Design and Development Verification and Validation Testing:When testing is necessary for verification and validation, are these tests planned, reviewed, controlled, and documented, to ensure and prove the following:39a)Do the test plans or specifications identify the product being tested and the resources that are to be used?1) Do they define the test objectives and conditions?2) Do they identify the test parameters that are to be recorded?3) Do they specify the relevant acceptance criteria?b)Do the test procedures describe the methods of operation, the performance of the test, and the recording of the test results?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsc)Are requirements specified to verify that the correct configuration of the product is being submitted for the test?39d)Are there provisions specified to ensure that the requirements of the test plan and the test procedures are complied with?e)Are there provisions specified to ensure that acceptance criteria are met?7.3.6.2 Design and Development Verification and Validation Documentation:At the completion of design and/or development, does the contractor's documentation and records ensure that reports, calculations, test data, inspection results, etc, demonstrate that the product meets the specification requirements for all operational conditions?407.3.7 Control of Design and Development Changes:Are design and/or development changes identified, documented, and maintained as records?41Do reviews of design and development changes include, evaluation of the effect of the changes on associated parts, and product already delivered?42Are design and development changes reviewed, verified, and validated, as appropriate, and are the changes approved, prior to implementation?43Are results of the review of changes, and any required corrective actions, maintained as records?447.4 Purchasing:7.4.1 Purchasing Control:Do the Subcontracting/Purchasing processes have adequate controls in-place, to ensure that purchased products, and/or services, conform to the Purchase Order requirements?45Are the types of controls, and to what extent they applied to the suppliers and purchased products, evaluated and dependent upon the effect of the purchased product on subsequent product processing, or the final product?46Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsDoes the contractor have adequate controls (e.g. policies, procedures, processes, etc) in-place, to accept responsibility for the conformity of all products purchased from suppliers, including product from suppliers mandated by the customer?47Are subcontractors/suppliers selected and evaluated, based on their ability to supply product, in accordance with the contractor's requirements?48Has the contractor's organization established procedures and criteria for selection, evaluation, and re-evaluation of suppliers?4950Are results of the evaluations, and any necessary actions taken, maintained as records?51Has the contractor established a process in the Quality Management System to:a)Maintain a register of it's suppliers that includes approval status (e.g. approved, conditional, disapproved), and the scope of the approval (e.g. product type, process family, etc)?b)Periodically review supplier performance, utilizing the results of the reviews as a basis for establishing the level of controls to be implemented?c)Define the necessary actions to take, when dealing with suppliers that do not meet requirements?d)Ensure that when required, both the contractor and all suppliers use customer-approved special process sources?e)Define the process, responsibilities, and authority for the approval status decision, changes of the approval status, and conditions for a controlled use of suppliers, depending on the suppliers approval status?f)Determine and manage the risk, when selecting and using suppliers?7.4.2 Purchasing Information:52Does the purchasing information describe the product to be purchased?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments53Do the Purchase Orders (purchasing information) to subcontractors and suppliers include:a)Requirements for approval of product, procedures, processes, and/or equipment?b)Requirements for qualification of personnel?c)Quality Management System requirements?d)The identification and revision status of specifications, drawings, process requirements, inspection/verification instructions, and other technical data?e)Requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance and related instructions for acceptance by the contractor, and if applicable, critical items, including key characteristics?f)Requirements for test specimens (e.g. production method, number, storage conditions, etc) for design approval, inspection/verification, investigation, or auditing?g)Requirements regarding the need for the supplier/subcontractor to:531) Notify the prime contractor of nonconforming product?2) Obtain prime contractor approval for nonconforming product disposition?3) Notify the contractor of changes to the product and/or process, changes of suppliers, changes of manufacturing facility location, and when required, obtain prime contractor approval?4) Flow-down in the supply chain, applicable requirements, including customer requirements?h)Retention of records?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsi)"Right of access" by the contractor, the customer, and regulatory authorities, to applicable areas of "all facilities", at any level in the supply chain involved with the order, and access to "all applicable records"?5354Are specified purchasing requirements evaluated for adequacy, prior to being issued to suppliers?7.4.3 Verification of Purchased Product:Has an inspection process, or other activities, been established and implemented, which are necessary for ensuring that purchased product complies with specified purchase requirements?55Has the contractor implemented an adequate process, to ensure that when purchased product is released for production use, pending completion of all required verification activities, that it is identified and recorded, to allow for recall and replacement, if it is subsequently found that the product does not meet requirements?56Does the contractor have procedures which define requirements for delegations, and require maintaining a register of delegations, for instances when the contractor chooses to delegate verification activities to the supplier?57Are verification arrangements, and/or methods of product release, specified in the purchasing information, where the contractor's organization, or it's customer, intends to perform verification at the supplier's premises?587.5 Production and Service Provision:7.5.1 Control of Production and Service Provision:Are the production and service provisions planned and carried out under controlled conditions, including:59a)Availability of information that describes the product characteristics?b)Availability of work instructions (e.g. travelers, routers, manufacturing plans, inspection documents, etc)?c)Use of suitable equipment (e.g. jigs, fixtures, molds, etc)?d)Availability and use of measuring and monitoring devices?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentse)Implementation of monitoring and measurement?59f)Implementation of release, delivery, and post-delivery activities?g)Accountability for all product during production (e.g. parts lists, parts quantities, split orders, nonconforming product, etc)?h)Evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized?i)Provisions for the prevention, detection, and removal of foreign objects?j)Monitoring and control of utilities and supplies (e.g. water, compressed air, electricity, chemical products, etc)?k)Understandable, clear criteria for workmanship (e.g. written standards, representative samples, illustrations, etc)?When planning controls for production, has the contractor considered, established, implemented, and maintain processes for:60a)Managing critical items, including process controls when key characteristics have been identified?b)Designing, manufacturing, and using tooling to measure variable data?c)Identifying in-process inspection and verification points, when adequate verification of conformance cannot be performed at later stages of production/realization?d)Special processes?7.5.1.1 Production Process Verification:61Has the contractor established and implemented a mandatory "First Article Inspection" process:a)Using a representative item from the first production run of a new part or assembly, to verify that the production processes, production documentation, and tooling, are capable of producing parts and assemblies that meet requirements?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsb)Incorporating provisions that the process shall be repeated, when changes occur that invalidate the original "First Article Inspection" results (e.g. engineering changes, manufacturing process changes, tooling changes, etc)?617.5.1.2 Control of Production Process Changes:Has the contractor established a method, process, and/or procedure for identification of personnel, authorized to approve changes to production processes?62Has the contractor implemented a process, to control and document changes affecting processes, production equipment, tools, or software programs?63Has the contractor developed and implemented a process, to evaluate the results of changes to production processes, assessing them to confirm that the desired effect has been accomplished, without adversely affecting product conformity?647.5.1.3 Control of Production Equipment, Tools, and Software Programs:Has the contractor implemented a process to ensure that production equipment, tools, and software programs, used to automate and control, or monitor product realization processes, are validated prior to release for production, and are maintained?65Has the contractor initiated a process, defining storage requirements, including periodic preservation and condition checks, for production equipment and/or tooling in storage?667.5.1.4 Post-Delivery Support:67Has the contractor established a post-delivery support process, which provides for the:a)Collection and analysis of in-service data?b)Actions to be taken, including investigation and reporting, when problems are detected after delivery?c)Control and updating of technical data?d)Approval, control, and use of repair methods?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments67e)Controls required for off-site work (e.g. contractor's work accomplished at customer's facilities)?7.5.2 Validation of Processes for Production and Service Provision:Have processes, where deficiencies may become apparent only after the product is in use, or the service has been delivered, been validated?68Do the results of validation, demonstrate the ability of the processes to achieve the contractor's planned results?6970Has the contractor established a system and processes for:a)Defining the criteria, for the review and approval of the processes?b)Approval of equipment, and qualification of personnel?c)Use of specific methods, and/or procedures?d)Requirements for records?e)Re-validation, if required?7.5.3 Identification and Traceability:71Is the product adequately identifiable, throughout the product realization processes?Does the contractor have a process, to maintain configuration identification of the product, in order to identify any differences between the actual configuration, and the agreed-to configuration?7273Is the product status identifiable, with respect to monitoring and measurement requirements?Has the contractor established a process, for control of "Acceptance Authority" media (e.g. stamps, electronic signatures, passwords, etc)?7475When traceability is a requirement, is the product uniquely identified and controlled?a)Is there a process to ensure that identification is maintained throughout the product life?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsb)Does the contractor have a process established, providing the ability to trace all products, manufactured from the same batch of raw material, or from the same manufacturing batch, to the destination (e.g. delivery, scrap, etc)?75c)For an assembly, does the contractor have a process established, providing the ability to trace components to an assembly, and then to the next higher level assembly?d)For a product, does the contractor have a process established, providing the ability to retrieve a sequential record of its production (manufacture, assembly, inspection, test, etc)?76Is the product's unique identification maintained as a record?7.5.4 Customer Property:Does the contractor exercise adequate care with customer property, while it is under the organization's control, or is being used by the contractor?7778Is customer property identified, verified, protected, and safeguarded?If lost, damaged, or otherwise found to be unsuitable for use, is the condition documented, reported to the customer, and maintained as a record?797.5.5 Preservation of Product:Is conformity of the product preserved during internal processing, and delivery to the intended destination?8081Do the contractor's preservation activities include:a)Identification?b)Handling?c)Packaging?d)Storage?e)Protection?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceComments82Are preservation activities applied to associated component parts of a product?In accordance with product specifications, and applicable statutory and regulatory requirements, does the contractor's preservation processes include provisions for:83a)Cleaning?b)Prevention, detection, and removal of foreign objects?c)Special handling for sensitive products?d)Marking and labeling, including safety warnings?e)Shelf life control and stock rotation?f)Special handling for hazardous materials?7.6 Control of Measuring and Monitoring Devices:Has the contractor's organization determined the monitoring and measurement to take place,and the types of monitoring and measurement devices that are required, to provide evidence of conformity to requirements?84Has the contractor established and maintained a register/record of monitoring and measurement equipment that is utilized?85Has the contractor established and defined the process, employed for the calibration and verification of monitoring and measurement equipment, including details of:86a)Equipment type?b)Unique identification?c)Location?d)Frequency of checks?e)Verification/check method?f)Acceptance criteria?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentsHas the contractor identified monitoring and measurement equipment, which is used to produce inspection data to provide evidence of product conformity, as including, but not limited to:87a)Test hardware?b)Test software?c)Automated Test Equipment (ATE)?d)Plotters?e)Personally owned equipment?f)Customer supplied equipment?Have processes been established, to ensure that monitoring and measurement can be carried out, in a manner consistent with the monitoring and measurement requirements?8889Has the contractor arranged for, and ensured that existing environmental conditions are suitable for:a)Calibration?b)Inspection?c)Measurement?d)Testing?90When necessary to ensure valid results, are measuring equipment:a)Calibrated or verified at specific intervals, or prior to use, against measurement standards that are traceable to international or national measurement standards; where no standard exists, is the foundation used for calibration or verification 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 results?Contractor:Date:AS9100C Audit ChecklistProgram PLAS Code:NumberQuestionProcess/Procedure ReferenceCommentse)Protected from damage and deterioration during handling, maintenance, and storage?90Has the contractor established, implemented, and maintained a process, for the recall of monitoring and measurement equipment requiring calibration or verification?91Has the contractor evaluated and recorded the validity of previous measuring results, when the equipment is found not to conform to the requirements, and have they taken the appropriate corrective action on the equipment, and any affected product?9293Are records of calibration and verification results maintained?When computer software is used in the monitoring and measurement of specified requirements, is the ability of the computer software to satisfy the intended purpose confirmed, prior to use?94Does the contractor's process, for confirmation of computer software to satisfy it's intended purpose, include verification and configuration management to maintain it's suitability for use?9596Is the ability of computer software, to satisfy the intended application, reconfirmed as needed?Notes & CommentsContractor:Date:AS9100C Audit ChecklistProgram PLAS Code:Notes & Comments

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