Presentation on theme: "SAE AS9100 Quality Systems - Aerospace Model for Quality Assurance"— Presentation transcript:
1 SAE AS9100 Quality Systems - Aerospace Model for Quality Assurance Presented By:Wil SanchezSFA Quality Assurance5/22/00
2 Overview of AS9100 Adds unique aerospace requirements to ISO 9001 Adds/Supplements to ISO 9001essential to product, process safety and quality of aerospaceContains management of “Key characteristics”Key characteristics are features of a material part or process whose variation has a significant influence on the fit., performance. service life, or manufacturablity of the product. Typically these key characteristics are identified by the customer on the design drawing, within the process specification or by the purchase order. The customer may also require the supplier to identify key characteristics. Once identified, the process or processes, which influence the variation of these characteristics, must be determined. These processes must be managed using statistical techniques to minimize their variation. When successful the resultant product conforms very close to it nominal requirements.Whether or not key characteristics are identified, the supplier is responsible to assure that ALL product features conform to specified requirements.Para. F 1. m. of the SQA Chapter of the One Book says, “Identify Key Systems, Processes, and Characteristics.” as part of the planning process. We are to review the contractor’s plans for satisfying contract requirements, considering those processes the contractor will use to satisfy contract technical and quality requirements.What might “Key Characteristics” on a drawing be called?“Key Characteristics”Safety of Flight (SOF)Fracture Critical FCCritical Characteristics (FCs)Interface Control Dimensions (ICDs))
3 The Twenty ISO Elements 4.1 Management Responsibility4.2 Quality System4.3 Contract Review4.4 Design Control4.5 Design Output4.6 Purchasing4.7 Control of Customer Supplied Product4.8 Product Identification and TraceabilityISO 9001 and AS9100 have the same basic 20 elements. The 20 elements have been greatly enhanced to accommodate the stringent requirements of aerospace. (I.e. lots of “teeth” in the aerospace standard!
4 The Twenty ISO Elements 4.9 Process Control4.10 Inspection and Testing4.11 Control of Inspection, Measuring and Test Equipment4.12 Inspection and Test Status4.13 Control of Nonconforming Material4.14 Corrective and Preventive Action
5 The Twenty ISO Elements 4.15 Handling, Storage, Packaging, Preservation and Delivery4.16 Control of Quality Records4.17 Internal Quality Audits4.18 Training4.19 Servicing4.20 Statistical Techniques
6 “Process Performer”Quality Assurance Activities may be delegated to the performer of that process.Procedures must define specific tasks and responsibilities which are authorizedProcess Performers must have corresponding requirements and training necessary to perform those tasks.Consistent with ISO 9001: Supplier not required to have a separate Quality organization.Delegation to process owner places responsibility for quality on those doing the work.Not only must do the work, but must assure it meets technical and quality requirements.Properly implemented, it increases product quality, eliminating the reliance upon inspection to sort good from bad.Provides instant feedback to operator on their performance, allowing them to adjust the process if required to produce error free productQ - Who’s responsible for assuring that the process owners are capably inspecting their own work?A - Contractor is always responsible. DCMC should assure contractor has a viable program to assure that process owners are able and doing their job properly?Q - What are some methods DCMC can assure that the contractor has controlled this system?A - Find good data collection points to assure that work coming out of key processes is not defective. If it is, find out why. What is contractor doing about it? Are they applying the lessons they learned to other process owners
7 4.2.4 Configuration Management (CM) New! More detail than ISO 9001Requires CM of the product during its entire life cycle to ensure safety and quality.Process must be documentedEncouraged to use ISO for guidance in establishing CM SystemConfiguration Management ‑The CM Process includes: ( Each of these items are discussed extensively in ISO 10007)Configuration IdentificationConfiguration ControlConfiguration Status AccountingConfiguration AuditingProduct Life Cycle includes: (1 ) Concept Exploration & Definition, (2) Demonstration and Validation, (3) Engineering (4)Manufacturing Development, Production and Deployment, Operations and Support)The management of the configuration of the product during its entire life cycle is essential to assure its safety and quality. This process must be established and documented. The system developer is encouraged to consult ISO for guidance in the establishment of the configuration management system.Product complexity and serviceability are just two of many factors that must be addressed during the configuration management process. Because this process touches the entire product life cycle the configuration management system must be addressed as a set of integrated processes.Q - What DCMC functional element(s) perform surveillance over this activity?A - Engineers, QASs, Software (TAG function at L.B) TAG & Ops should plan oh how they work together in this oversightQ - What are some methods that can be used to surveil the CM process?
8 188.8.131.52 Documentation of Design Verification and Validation Reports, calculations, test results, etc. must demonstrate that the product definition meets the specification requirements for all identified operational conditions and the product will function correctly.This element of the standard only applies to the suppliers who are responsible for the design of their product. Design is a Pre- Production function, conducted by engineering.Following the completion of the verification and validation testing the test data which demonstrates that the product conforms with design input and specification requirements shall be reviewed to assure that the desired design output has been accomplished. This data and the resultant review become a quality record.The planning, control, review and documentation of verification and validation tests is essential to assure that adequate testing has been accomplished to assure that the design accomplishes the desired results. The decisions on what type of testing is required and what characteristics of the design are being verified by each test should be documented. The data to be recorded and the acceptance criteria should also be documented. Where the sequence of testing is of importance this shall be included within the test plan. The plan shall also identify all resources required, including equipment, materials, facilities, personnel, energy sources and the associated costs.Q - Is test documentation important?Q - Can the test data have simple yes or know, pass or fail data or must it show the test data results with criteria? A- Must show test results and criteriaQ - Who in your organization could review the process to assure it is performing well? I.e. assure that design input and spec requirements have been accounted for in the test)Q - Who in your organization could surveil the process to determine if the supplier has reviewed the test data? How often should this be done? (Depends on the risk level)Is test data to be considered a permanent quality record?
9 184.108.40.206 Design Verification and Validation Testing Tests shall be planned, controlled, reviewed, documentedTest Plans identify product tested, resources used, test objectives/conditions, test parameters, acceptance criteriaTest Procedures describe method of operation, performance of test and recording of resultsCorrect configuration standard of the tested productTest plan requirements and procedures are observedAcceptance criteria is metTest procedures shall be written for each test. These can utilize existing procedures and documented processes. At a minimum the procedures shall describe the equipment to be used in conducting the test, the test setup, the test methods, the acceptance criteria, qualifications of the personnel performing the test and the data to be recorded.Prior to beginning the test the configuration of the item being tested shall be verified to validate that it conforms to the required item to be tested. This action is essential to assure that the configuration of the item is known.During the test, evidence should be provided to validate that the test plan and procedures were met. This can be accomplished by using checklists, taking photograph or video of the test setup, obtaining independent verification of the test practices and a number of other validations approaches. It is important that the method of verification be agreed to before the test begins.This is especially important when customer or regulatory agencies will rely upon the test results. Failure to accomplish this action may result in having to conduct the test a second time.At the conclusion of the test, verification must be provided that all acceptance criteria have been met. This may be as simple as the review of a few items of the test results. In the case of sophisticated system tests independent experts may be engaged to review a comprehensive set of test data to independently validate the satisfactory accomplishment of the test program. Again, this process should be documented prior to the initiation of the tests to preclude any disagreement at the conclusion of the tests. Any deviation from the test process and anticipated test results must be documented and dispositioned.Q - How might we surveil validation testing? A - Compare test procedures to acceptance criteria, Check test set up. Check Test results. Assure correct configuration of product vs. test procedureQ Who should do it? A - Engineering personnel mostly; QA personnel can take part
10 4.5.3 Document and Data Changes Timely review, distribution, implementation and maintenance of all authorized and released drawings, standards, specifications, planning and changesRequires a record of change incorporationCoordinate changes with customer if requiredThis element applies to all documents which control the design and manufacture of the product (I.e. engineering drawings, fabrication and assembly orders, computer generated planning and design, test procedures, tech data, etc.)The aerospace industry is relying more and more upon digital data to communicate design. Digital data provides several advantages in that the product can be produced directly from this data definition without the intervention of master models and tooling. The process for controlling the development, release, distribution and updating of this data must be documented. It must provide for adequate safeguards to assure the integrity of the data being used to produce and verify the product. Configuration management is an essential element of this process.Changes to the design are made to address changes in customer requirements.. Each of these changes is accompanied with an effectivity that specifies the anticipated implementation of these changes. The supplier is responsible for maintaining a process which assure the correct incorporation and documentation of these changes. This process must cover drawings, standards, specifications, planning and purchase orders. (subcontract management function)Typically within the aerospace industry design changes are classified as either Class I or Class 2. Class one changes are those that effect safety, fit, form. function, interchangeability, maintainability or reliability. Class two changes are those that impact none of the above. In some cases the customer may allow the supplier to make Class 2 changes without notification. The supplier must understand his responsibilities for communicating design changes to customers and/or regulatory agencies. This process must be documented.Q - What are “Class One” Changes and who generally must approve them? A - Those that effect safety, fit, form. function, interchangeability, maintainability or reliability. Approved by PCOQ - If determined to be “Low Risk,” can we post-review Class II ECPs? A - Yes. The Config. Mgmt Chapter of the One Book allow us post review class II ECPs), if the process is Low risk.
11 4.6.1 Purchasing“The Supplier shall be responsible for the quality of all products purchased from subcontractors, including customer-designated sources.”PurchasingThe supplier is responsible for the quality of all products and services purchased from subcontractors. This includes the quality of products and services procured from sources designated by the customer.Suppliers must have in place a process for approving the quality systems of their subcontractors. This process must include the individual or organization responsible for performing these reviews and granting the approvals. Once a supplier has been approved a process must exist that periodically reviews the performance of the supplier. The supplier must maintain a list of all approved subcontractors. This list should include the scope of each approval and may need to designate the type of work which each subcontractor is approved to perform.Who is responsible for subcontracted supplies? A- The Prime SupplierWho do we take action with if subcontractors are not performing well? A- The PrimeWhat are some surveillance methods we might use to provide us insight into the Supplier’s control of their subcontractors? A - Review data at Receiving Inspection; Review MRB data of suppliers; Review any nonconformance data that points to subcontractor problems; Determine if corrective action has been effective; Review Prime contractor’s audits of his subcontractors
12 4.6.2 Evaluation of Subcontractors Ensure, when required, that supplier uses customer approved special process sources.Ensure that Organization which Approves subcontractors have authority to disapprove themReview & record SubK performance, using results as basis for extent of subcontractor controlDefine (in procedures) action to take when subcontractors under-perform.Evaluation of Subcontractors ‑In addition to the responsibilities for evaluating subcontractors as specified in ISO 9001, the supplier shall also assure that they and their subcontractors use customer‑approved special processing sources when such sources are required in the process specification or purchase order. Special processes are those processes, the output from which cannot be readily identified using ordinary inspection techniques. Such special processes include heat treatment, plating, painting, and nondestructive inspection to name just a few.Suppliers must have in place a process for approving the quality systems of their subcontractors. This process must include the individual or organization responsible for performing these reviews and granting the approvals.Once a supplier has been approved a process must exist that periodically reviews the performance of the supplier. The requirements for this review must be documented and records maintained of these reviews. If the supplier relies upon the performance of the supplier to adjust his level of supplier control then the criteria for this adjustment must be documented.The supplier must maintain a list of all approved subcontractors. This list should include the scope of each approval and may need to designate the type of work which each subcontractor is approved to perform. The procedure should mandate the use of this list when selecting suppliers.Q - Who approves subcontractors? A - Prime supplierQ - What constitutes approval? A- Must have criteria in their proceduresQ - How often does the Supplier have to review the performance of his subcontractors? A - Depends on his procedures.Q - What determines the Suppliers degree of control over subcontractors? A - Should say in his procedures. Should depend upon performance.
13 4.6.3 Purchasing Data Purchasing documents shall contain: design, test, examination, inspection, customer acceptance requirementsRight of access by purchaser, customer to all facilities involvedrequirements for test specimens for design approval, inspection, investigation or auditingrequirements relative to notification of anomalies, changes in definition, and approval of their processingRequirements to flow down applicable requirements and key characteristics where required.The purchase order shall clearly specify if design, test, examination, inspection and customer acceptance data is required from subcontractors.The purchase order shall also specify that the supplier, the supplier’s customers, and regulatory authorities shall have access to the subcontractor’s facilities and all applicable quality records.When test specimens are required to support design approval, inspection, investigation or auditing the requirement shall include the production method, quantity, storage condition and other parameters essential to the integrity of the samples.The supplier shall include the method to be used by the subcontractor in notifying the supplier when nonconforming product, processes or other anomalies occur. The intent is to assure a document process exists that facilitates the ability of the subcontractor to communicate with the supplier.Specific requirements of a purchase order that the subcontractor must flow down to his subcontractor must be identified. This includes key characteristics when the subcontractor has the responsibility for managing the variability of these characteristics.Q - Who determines if the GSI clause will be included in the purchase order? A - QARQ - When are some examples of when we should require GSI at the Subcontractor level? A - (See FAR ) Direct shipment to customer; Mandatory inspection required by customer that can’t be performed at the prime; performance at any other place would destroy or require the replacement of costly special packing or packaging or would require uneconomical disassembly or destructive testing.Q - Who is responsible for the subcontractor’s product? Prime
14 4.6.4 Verification of Purchased Product The supplier shall implement procedures to verify purchase product including:obtaining objective evidence of quality (documentation, CoC, test reports, statistical records, process control,etc.)Inspection at sourceReview of the required documentationInspection of products at deliverydelegation of verification to the subcontractor (supplier shall define the requirements for delegation and maintain a list of delegations).The supplier has a number of methods available for controlling the quality of the products and services that they obtain from their subcontractors.The selection of the appropriate method(s) and their use is the responsibility of the supplier.Alternate approaches used by a supplier shall be documented and the method of selecting the appropriate technique explained. AS9100 allows a broad number of methods of delegation of verification to the subcontractor. If delegation is used, the supplier shall define the requirements for delegation and maintain a list of those suppliers to which product acceptance has been delegated.Q - Which method must the supplier use to control the quality of the products from their subcontractors? A- Supplier has latitude to select any method that works.Q - What does “delegation of verification to the subcontractor mean? A- Supplier allows the subcontractor to inspect his own product and assure its integrity.Q - What is the criteria for delegating verification to the subcontractor and what are the limits? A - All of this must be explained in the Supplier’s procedures. The criteria and limits must be of sufficient control to assure the supplier only delivers conforming product.
15 4.8 Product Identification and Traceability In accordance with contract and requirements, Supplier’s system shall provide for:Identification maintained through product lifeTraceability of all products from the same batch of raw material or manufacturing batch, as well as the destination of all products to the same batch.Identity of components and those of next higher assembly to be tracedA sequential, retrievable, traceable record of production (manufacture, assembly, inspection)Identification of configuration of the actual productAerospace products must perform for a significant period of time. Some are used in very critical applications. The standard specifies specific situations that may be required:If the product requires identification throughout the product life cycle the identification method must be robust enough to survive the product usage. The method of identification shall not negatively impact the performance or safety of the product. Typically the specific method and location of identification is specified in the engineering drawing or supporting process specification.If the product requires traceability of all parts produced either from the same raw material source or during the same manufacturing process then a system must exist to know the existence of each part and its final destination. This system must be dynamic enough to allow the fielded product to be moved to alternate sources.It may be required to know the specific parts contained within an assembly and then its location in the next higher assembly. If the assembly has components that can be changed then a process must exist for knowing the ongoing status of the assembly and its contents.In a number of instances what is important is a sequential record of the production processes used to produce the product, the equipment and tooling used, the personnel involved and the results of inspections and tests.All of the above constitute quality records and are subject to the requirements of paragraph 4.16 of ISO 9001
16 4.9.1 Process Control Controlled conditions include the following: Temperature, humidity, lighting, cleanliness, etc.Monitoring and Control of Key CharacteristicsAccountability of all product during manufactureEvidence that all manufacturing and inspection operations have been completed as plannedProvision for the prevention, detection, and removal of foreign objectsUtilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product qualityThe control of the temperature, humidity, lighting and cleanliness may be essential to achieving the level of quality necessitated by the industry. When these can be a factor they must be controlled.If the purchase order or internal requirements require the monitoring and control of key characteristics the quality system shall document the control processes used. The objective of these processes is to minimize the variation of the characteristics through a management of the process characteristics that influence these characteristics.During the manufacturing process it is important that the supplier account for all items introduced into the Production stream. If a batch of 20 pieces are started then when the batch is completed the status of all 20 should be known. Along the way the batch may have been broken into two smaller batches to allow a few parts to be expedited to meet an immediate need for spare parts.. Whatever the case, the supplier must be able to account for every piece.The production work instructions typically include provisions for those doing to work to indicate who performed the work and when. The provisions are made for those verifying the quality of the work performed. At the completion of the work the work instructions shall be reviewed to assure that all of the manufacturing, and inspection operations have been performed or that specific authorization exists for deviating from this practice.In the aerospace industry Foreign Objects (FO) can threaten the safe operating performance of the product. The history of aviation is blemished by instances of flashlights. mirrors. loose parts, tools, rags and other items. not part of the designed configuration (Foreign Objects). becoming jammed in a control cable. control rod or control surface or shorting out an electrical system. The best way to preclude FO is to prevent its interjection into the aircraft and to continuously review the product to identify and remove the FO. Approaches to accomplish this include tool identification and accountability, clean as you go programs which remove all FO (including drill chips, tooling, loose parts. etc.) at the end of every shift and distinctive marking of flashlights, tools and protective items to make them visible. Many more approaches have been found acceptable. Specific detection processes should be included in the planning prior to the closing up of areas and the installation of parts and insulation that may cover up a FO. The process for FC control is dependent upon the item being produced and its propensity for containing FO. Assistance in developing effective FO programs is available from industry associations and from the prime manufacturers.Processes can be influenced by a number of factors. The humidity level of the compressed air can effect the operation of pneumatic tools and the chemical composition of water may contaminate a cleaning process. Chemical products used for cleaning if not property controlled may leave vapor residue on adjacent surfaces. The consistency of electrical power can cause fluctuations in test results and variation in plating and soldering processes. The impact of changes in the quality of utilities and supplies must be understood and controlled to the extent necessary to preclude changes in the quality of the affected product.
17 220.127.116.11 Production Process All New Requirements! Production DocumentationControl of Production Process ChangesControl of Production Equip, Tools & NC MachinesControl of Work Occasionally Performed Outside the Supplier’s FacilitiesProduction Documentation ‑ The production documentation shall include all of the data necessary to consistently produce the product or perform the process. These may include drawings, part lists, and process flow charts including inspection operations. The production work instructions and inspection documents shall be clearly identified and linked to the appropriate configuration of product being produced. Typical types of production work instructions include manufacturing plans, travelers, routers, work orders and process cards. When specific tooling is required it shall be identified within the work instructions. This includes the programs to operate numerical controlled machines.Specific categories of documents requiring control are those associated with tools that are designed to produce a specific part or series of parts. This special tooling shall have its design documented. The instructions for producing the tooling and verifying its conformance shall also be controlled as well as records maintained of its use and maintenance.Control of Production Process Changes ‑ When it becomes necessary to change a production process these changes must be documented. Design changes, producibility enhancements, process improvements, variation in sources of raw material, and a number of other factors may necessitate changes. The reason for the change shall be documented.The production change process shall identify those authorized to make changes to the production processes. If customer approval is required this shall be identified and the method for notifying the customer explained.Any changes to processes. production equipment, tools and programs that may effect product quality shall be documented. The procedures for implementing these changes shall be available. Every change to the material tested using an independent source or witnessing the subcontractor's inspection and test process. The process used by the supplier shall be documented.The item of importance here is discipline and documentation. The supplier cannot make changes to his production system without documenting what he’s done. All production processes must have discipline to them and be documented so as to consistently put out a good product. When we proof a process, we expect the process to continue to follow the documented procedures until the procedures are changed.
18 4.9.2 Special ProcessesSpecial Processes shall be identified and qualified prior to useControl applicable aspects of special processes as defined by process specs.Define the significant operations/parameters in the process to be controlled during productionA number of processes performed within the aerospace industry do not lend themselves to having their results verified after-the fact by inspection and testing. These include plating, heat treatment, chemical processing and non-destructive inspections. These processes are typically managed by using qualified operators in conjunction with in-process monitoring and control of process parameters. When production operations required the use of special processes these processes shall be clearly identified and qualified prior to use. The supplier shall assure that applicable controls are in place as defined by the process specification. Specific attention shall be paid to process changes. The supplier shall identify the specific process parameters in the process that will be controlled during production and identify the data that will be recorded.
19 4.10.1 Inspection and Testing Procedures shall include:Identification of authorized personnelLimits of authorizationtraining and qualification requirementsInspection and TestingThe documented procedures for inspection and test activities shall specify the resources and methods to be implemented as well as the method of recording the results. The identification of authorized personnel, including any limitations to this authorization, and the associated training and qualification shall also be documented.The supplier shall perform the maintenance and control of the inspection documentation. This documentation may be part of the manufacturing work instructions or other manufacturing documentation. The documentation shall include acceptance and rejection criteria. where in the manufacturing sequence the verification activity is to be performed and how the results of the inspection are to be documented. The inspection instruments to be used shall be identified either within the specific work instructions or by use of a supplementary standard. When special inspection equipment is required the documents associated with their design, production. validation. control, maintenance and use shall be controlled.If the supplier subcontracts inspection or test activities to another organization the supplier shall control the performance of this subcontractor consistent with the requirements of section 4.6, Purchasing. While the supplier can delegate the performance of the work to another organization, he remains responsible for the quality of the work performed.
20 4.10.1 Inspection and Testing (Cont.) Inspection Documentation shall include:Acceptance/Rejection CriteraSequence of inspection and testingDocuments recording inspection resultsIdentification of production/ Inspection InstrumentsDocuments indicating inspection instruments are controlledControl of Subcontractors performing inspectionsThe supplier shall perform the maintenance and control of the inspection documentation. This documentation may be part of the manufacturing work instructions or other manufacturing documentation. The documentation shall include acceptance and rejection criteria. where in the manufacturing sequence the verification activity is to be performed and how the results of the inspection are to be documented. The inspection instruments to be used shall be identified either within the specific work instructions or by use of a supplementary standard. When special inspection equipment is required the documents associated with their design, production. validation. control, maintenance and use shall be controlled.If the supplier subcontracts inspection or test activities to another organization the supplier shall control the performance of this subcontractor consistent with the requirements of section 4.6, Purchasing. While the supplier can delegate the performance of the work to another organization, he remains responsible for the quality of the work performed.
21 Receiving and TestingWhen using Certification test reports, supplier shall assure data in said reports are acceptable per applicable specification.The supplier shall periodically validate test reports.Receiving Inspection and Testing ‑ Certification Test Reports ‑ The use of certified test reports is relied upon within the industry as one method of accepting material. When the supplier chooses to use this method he shall assure that the data in the test reports are acceptable to the applicable specifications. This step is necessary to assure that the material tested complies with the specifics of the specification, which may be different from the more generic requirements of the basic material. The supplier shall also periodically validate the test reports. Two methods, among several, to validate to perform this validation are having the material tested using an independent source or witnessing the subcontractor's inspection and test process. The process used by the supplier shall be documented.Q - What is an example of test certification reports? A- CoCQ - What are some methods that the contractor can use to assure CoCs are acceptable? A-Having the material tested using an independent sourceWitnessing the subcontractor's inspection and test processReviewing raw data do anAudit of the facility.
22 4.10.5 Inspection and Test Records Test records shall show actual test results data when required by specification or acceptance plan.Where required to demonstrate product qualification, supplier shall ensure that quality records provide evidence that the product meets the defined requirements.Inspection and Test Records ‑ The specification. acceptance test plan or purchase order may require the supplier to record actual test data. The process for performing this work shall be documented.If the supplier is required to demonstrate product qualification the supplier shall ensure that the quality records provide the evidence that the product meets the defined requirements. This is most easily accomplished by a complete listing of all qualifications, including the acceptance criteria and then a recording of the actual qualification results adjacent to these criteria. Care must be exercised in the performance of qualification testing to assure that the product tested is conforming and that the test processes and procedures are carefully and completely followed. Qualification testing can be an expensive and time consuming activity and every effort should be made to allow successful completion on the initial submittal.
23 4.10.6 First Article Inspection (FAI) Supplier’s system shall provide a process for inspection, verification, documentation of the first production articleFAI documentation shall be retained and include design characteristics, tolerances with actual measurements and testing resultsFAI Inspections shall be updated to include production process changes or configuration changesDon’t show this slide! N/A at Long Beach.First Article Inspection ‑ The aerospace industry relies upon a detailed inspection and test of an early production article to provide objective evidence that the manufacturing process can yield a conforming product. Different customers interpret the term First Article differently and the supplier should ascertain from their customer if the article must be the first item produced, the first item that conforms to the requirements or a representative item produced early the production run.The supplier shall document his process for the inspection. verification and documentation of the first article. The results of the verification shall include a list of the design criteria and any allowed tolerances and the actual results of the inspections and tests. Some customers may require the recording of additional information including the type of equipment used to perform the inspection or test, the identify of the person performing the inspection or test and the atmospheric conditions during the inspection or test. The results are considered quality records.When the production process is changed or the configuration revised, the supplier shall perform a partial or complete first article inspection, depending upon the extent of the change.
24 4.11.1 Control of Inspection, Measuring & Test Equip. Includes, but not limited to:test hardwaretest softwareAutomated Test Equipment (ATE)Plotters use to produce inspection dataPersonally owned equipment used for product acceptanceResponsibilities shall be defined regarding control of all such equipment.Control of Inspection, Measuring and Test Equipment ‑ The definition of what constitutes inspection. Measuring and test equipment within the aerospace is very broad. It includes all devices used to determine that the product conforms to the engineering design. (1) Since assembly equipment is frequently used to demonstrate that the product conforms, this equipment when used for demonstration of conformance, is included within the definition. (2) Computer driven plotters are used to develop to make full size transparencies of the product and these are then used to verify that the product conforms to the template. These plotters are defined as inspection test equipment unless a separate inspection operation is performed on the template to validate its conformity. These are but two examples that demonstrate the breadth of the aerospace definition.Simply stated, all equipment that is used by a supplier to validate that materials, products, processes or other inspection, measuring or test equipment conforms to stated requirements is defined as inspection, measuring and test equipment and must be controlled and managed per the requirement of section 4.11.The responsibilities for the control of inspection, measuring and test equipment including its calibration shall be defined. This shall include personally owned tools and customer furnished tools. A list of all this equipment shall be maintained. The process for notifying organizations and personnel that measuring devices require calibration and the method of effecting this recall shall be defined. This process should preclude the use of equipment that requires calibration being used to perform inspections and tests.When a piece of equipment is found to be out of calibration to the extent that it can potentially impact the results of its use, the supplier shall disposition any product that may be nonconforming. This requirement has existed for a long time within the industry. It still provides challenges in its application. When a piece of equipment is found to be outside its calibrated limits an analysis should be performed to determine if the nonconformance of the equipment has any impact on the product accepted by the equipment. If the quality of the product can be compromised because of the equipment then the product must be dispositioned. typically using a process similar to that used to process other nonconforming material.
25 4.12. Inspection and Test Status Authorized Personnel: Records shall identify personnel authorized to verify, certify and release productsAcceptance Authority Media: Acceptance media (e.g. stamps, electronic signatures or passwords), shall have documented controlsInspection and Test Status ‑ The aerospace industry customarily uses stamps. electronic signatures and passwords, commonly referred to as acceptance authority media, to identify the acceptance of product and the associated records. When acceptance authority media is used the supplier shall establish a process for the control of this media. Typically this media includes the configuration of the media, the method of issuance and tracking and a listing of the personnel that are assigned this media.Persons that are authorized to verify, certify and release product must be identified. This includes all personnel that have been delegated these responsibilities.
26 4.13 Control of Nonconforming Product MRB Members: Procedures must define processMaterial Review Authority for UAI and RepairRegrading MaterialScrap MaterialNotificationMRB Members: The suppliers documented procedures shall define the process for approving personnel making material review decisions.Material Review Authority: The supplier shall not use dispositions of “use-as-is” or “repair,” unless specifically authorized by the customer.Regrading Material: Product dispositioned for regrade requires a change in product identification to preclude the product’s original use. Adequate test reports and certs shall reflect the regrading.Scrap Material will be conspicuously and permanently marked and controlledNotification: When the supplier becomes aware of a nonconformity that may effect delivered product he shall notify the customer in a timely manner. Notification shall include a clear description of the nonconformance, which includes as necessary the parts affected, customer and/or supplier part numbers, quantity and date of delivery. If continuing airworthiness actions are required they must be noted and clearly communicated. The supplier, working with the customer, shall determine if the air‑worthiness authorities should be notified and if so, by whom.FAR requires the supplier to not tender for acceptance supplies that are nonconforming without disclosing that fact to the government.FAR allows (unless specifically withheld by the contracting office) the cognizant CAO to accept or reject minor nonconformances
27 4.14 Corrective ActionFlow-down of Corrective Action requirement to subcontractorSpecific action where timely and/or effective corrective actions are not achievedCorrective and Preventative Action ‑ An effective quality system includes a robust process to eliminate the causes of actual or potential nonconformities. This system shall verify that the actions taken have been effective in eliminating the root cause of the nonconformance. This type of process is typically referred to as closed-loop.Corrective Action ‑ The supplier shall assure that the requirement to maintain an effective corrective and preventative action system is flowed down to all subcontractors. The suppliers shall document the process for responding to situations where the corrective actions are not timely and/or effective.
28 4.15.1 Handling, Storage, Packaging, Preservation and Delivery These procedures include the following:CleaningPrevention, detection and removal of foreign objectsspecial handling for sensitive productsmarking and lableling including safety warningsshelf life control and stock rotationhazardous materialsaccompanying documents for product are present at delivery and protected.Handling, Storage, Packaging, Preservation and Delivery ‑ The suppliers procedures for handling, storage, packaging, preservation and delivery of product shall specifically cover, where applicable:The method of cleaning and preserving products during the production process and at its conclusion.The method for prevention, detection and removal of Foreign Objects as discussed in section on Process Control.The method of handling sensitive products including such products as those that are sensitive to damage by electrostatic discharge.The method of marking and labeling the product and its packaging, including safety warnings.The methods for assuring that life limited items are properly rotated when in storage and that out of life parts are not included within assemblies nor delivered.The methods used to identify and manage hazardous materialsThe above processes can have a negative impact on product quality if not properly managed. Care shall be given to assure that all affected employees understand and execute their responsibilities.The documents that are required at product delivery are specified in the contract, purchase order or referenced specifications. The supplier shall ensure that these documents are available at time of delivery and that they are protected from loss or deterioration.
29 4.17 Internal Quality Audits Conduct internal quality audits that assess quality systemQuality manual and working level procedures must reflect requirements of AS9100Develop tools (e.g. checklists, flowcharts, etc. to support audit of requirementsDeveloped tools will effectively measure supplier performanceInternal Quality Audits ‑ The internal audit process in conjunction with an effective set of internal and external performance measures will provide an adequate picture of the health of the quality system. Personnel performing the audits should be trained organizationally independent from the immediate area being audited. Effective audits will look at several of the quality system elements concurrently. This higher level, systems approach is important to continuously verify that the elements are properly integrated.The audits shall assure that the quality system design complies with the requirements of SAE AS9100 and that the operation of the system is in compliance with the quality manual and implementing procedures. A clear flow down of the requirements of AS9 100 to the supplier's quality manual and to the working‑level procedures shall be demonstrated. Detailed procedures for conducting the audits shall be developed. The establishment of checklists and process flow charts are encouraged to facilitate the audit process. It is important to remember that these are only tools and that they should not be used to the exclusion of anobjective, top‑down review process. The effectiveness of the audit process should be periodically evaluated to assure that the results of the audit are consistent with the input received from customer satisfaction data and internal escape information.Personnel performing the audits must be trained. It is strongly encouraged that this training be consistent with the guidance provided in ISO
30 4.18 Training“Training to achieve and maintain an awareness and understanding of relevant procedures and instructions shall be provided.”Training ‑ Adequate training is essential in the implementation of an effective quality system. The amount of training required is determined, in part. by the decisions made regarding the extent and detail of the implementing procedures and work instructions.Suppliers choosing to provide detailed instructions will need to do less in-depth training. Those that choose to maintain only high level procedures and production processes must assure that those using these documents understand the actions necessary to successfully implement the desired practices.It is important that all personnel understand the supplier's approach to implementing the quality system. They must be aware of the procedures and instructions that are relevant to performing their work, know how to access these documents and be aware of the process for requesting changes. They also must understand that no deviation can be made from the procedures or work instructions without formal revision of these documents.
31 4.19 ServicingWhen servicing is a specified requirement, suppliers procedures shall contain:Method of collecting and analyzing in-service dataActions to be taken for identified problemsControl and updating of technical documentationApproval, control of repair schemesRequired controls to work off-site (e.g. customer’s facilities)Servicing ‑ As previously emphasized, products within the aerospace Industry are frequently designed to operate for 30 to 40 years. This means that periodic maintenance must be performed and that some of this maintenance is extensive. Technical documentation is required to support the maintenance function This information must be formally released, controlled and updated in a manner that assures that those using this information are aware of the revisions. When the owner or operator of the equipment must perform repairs that are outside of the scope of the published documentation a formal process must exist for the approval, control and use of this repair scheme. To the extent that the supplier is involved in performing service activities at a customer's facility, the procedures for performing this work and verifying its quality must be documented in the quality system.Information received from the field regarding the performance of the product is an important indicator of the effectiveness of the quality system and should be used during the management review. It also provides valuable information for those designing and producing the product regarding areas for improvement. Customer satisfaction is essential to retaining existing customers and growing the business. The systematic use of in‑service data can enhance this relationship. The quality system must also document the process used when problems are identified after delivery. This shall include the method used to investigate and report the incident. The process shall also document how corrective actions are taken to eliminate the root cause, the methods of implementing the resultant changes required and the associated reporting activities. This should include a process for advising other customers if a similar problem might exist on a product provided by the supplier and, when appropriate,. the method used to notify the regulatory agencies.
32 4.20 Statistical Techniques Supplier shall develop procedures to control statistical techniques used for such things as:Design verificationProcess controlInspectionQuality ManagementFailure Mode and Effect AnalysisStatistical Techniques (Called Procuct Variability Reduction (PVR) at L.B)‑ The proper use of statistical techniques can provide an effective method for assuring product quality and for developing product and process improvements. The effective use of statistical techniques can span the entire product life cycle. Many of the engineering disciplines rely heavily upon statistical methodology when performing safety, reliability and maintainability projections. The test laboratories may make extensive use of experimental design to determine the optional product configuration or process parameters.Within manufacturing, statistical techniques are essential to achieve process control and variability reduction. The are used in establishing key product and process characteristics, in conducting gauge repeatability studies, in taking process performance measurements and computing the resultant capability, and in establishing statistical process control methodology. Design of experiments is being used to analyze and improve process performance.Sampling inspection has a long history within the aerospace industry. Understanding the underlying theory behind these methods is essential to their proper application. Within the industry it is generally agreed that when sampling inspection is used for product acceptance that the plan must preclude the acceptance of known defectives. This means that only sampling plans that have an "accept on zero, reject on one" acceptance criteria shall be used. The customer may require that the sampling plan be submitted for approval.The application of statistical methodology to the understanding and analysis of field dam may yield significant results. This can include the use of failure modes and effects analysis to determine the underlying cause of lower than expected reliability. Product performance data can be analyzed and compared to reliability and availability projections to determine if the product is performing in the anticipated manner.At the quality system level. statistical techniques may be beneficial is analyzing the performance of the quality system and identifying areas for improvement. Recently emerging simulation technology may assist in this effort. As in all areas of the quality system implementation. it is essential that those using statistical techniques be adequately trained.