• Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

Audit Preparation

  • Review corrective actions for previous IA findings

  • Review corrective actions for previous EA findings

  • Review corrective actions for any customer complaints

  • Review corrective actions for any customer audit findings

7. Product Realization

7.1 Planning of Product Realization

  • Has the organization planned & developed the processes needed for realization of product?

  • In planning product realization, has the organization determined the following, as appropriate:

  • a) Quality objectives and requirements for the product?

  • b) The need to establish processes and documents and provide resources specific to the product?

  • c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;<br>

  • d) records are needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4);<br>

  • AS9100C - e) configuration management appropriate to the product;

  • AS9100C - f) resources to support the use and maintenance of the product. Is the output of this planning in a form suitable for the organization’s method of operation?<br><br>

  • AS9100C - Note: Quality objectives and requirements for the product include consideration of aspects such as:

  • a) product & personal safety,

  • b) reliability, availability & maintainability,

  • c) Producibility & inspectability,

  • d) Suitability of parts & materials used in the product,

  • e) Selection & development of embedded software, and

  • f) Recycling or final disposal of the product at the end of its life.

  • NOTE 1: A document specifying the processes of the quality management system (including the product realization processes) and resources to be applied to a specific product, project or contract can be referred to as a quality plan.

  • NOTE 2: The organization may also apply the requirements given in 7.3 to the development of product realization processes.

7.1.1 Project Management

  • AS9100C - As appropriate to the organization and the product, does the organization plan and manage product realization in a structured and controlled manner to meet requirements at acceptable risk, within resource and schedule constraints?

7.1.2 Risk Management

  • AS9100C - Has the organization established implemented and maintained a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product:

  • AS9100C - a) assignment of responsibilities for risk management<br><br>

  • AS9100C - b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance)<br><br>

  • AS9100C - c) identification, assessment and communication of risks throughout product realization<br><br>

  • AS9100C - d) identification, implementation and management actions to mitigate risks that exceed the defined risk acceptance criteria, and<br><br>

  • AS9100C - e) acceptance of risk remaining after implementation of mitigating action<br><br>

7.1.3 Configuration Management

  • AS9100 C - Has the organization established, implemented & maintained a configuration management process that includes, as appropriate to the product:

  • AS9100C - a) configuration management planning

  • AS9100C - b) configuration identification<br><br>

  • AS9100C - c) change control

  • AS9100C - d) configuration status accounting, and

  • AS9100C - e) configuration audit.

7.1.4 Control of Work Transfers

  • AS9100C - Has the organization established, implemented and maintained a process to plan and control the temporary or permanent transfer of work (e.g., from one organization facility to another, from the organization to a supplier, from one supplier to another supplier) and to verify the conformity of work to requirements?

7.2.1 Determination of Requirements Related to the Product

  • How does the organization to determine:

  • a) requirements specified by the customer, including requirements for delivery and post-delivery activities?

  • b) Product requirements not specified by the customer but necessary for intended or specified use, where known?

  • c) Regulatory and statutory requirements related to the product, and?<br>

  • d) any additional requirements considered necessary by the organization?<br>

  • AS9100C - Note: Requirements related to the product can include special requirements.

  • NOTE: Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.

7.2.2 Review of Requirements Related to the Product

  • Does the organization review the requirements related to the product?<br>

  • Is this review conducted prior the organization’s commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and to ensure that:<br>

  • a) product requirements are defined?

  • b) contracts or orders requirements differing from those previously expressed are resolved?

  • c) the organization has the ability to meet the defined requirements?

  • AS9100C - d) Special requirements of the product are determined? And

  • AS9100C - e) risk (e.g., new technology, short delivery time frame) have been identified (see 7.1.2)

  • Are records of the results of the review and actions arising from the review maintained?

  • Where the customer provides no documented statement of requirements, are the customer requirements confirmed by the organization before acceptance?

  • Where product requirements are changed, does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?

  • NOTE: In some situations, such as internal sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

7.2.3 Customer Communication

  • Has the organization determined & implemented effective arrangements for communicating with customers in relation to:

  • a) Product information?<br>

  • b) Enquiries, contracts or order handling, including amendments? and<br>

  • c) Customer feedback, including customer complaints?<br>

7.4.1 Purchasing Process

  • How does the organization ensure that purchased product conforms to specified purchase requirements?

  • Is the type & extent of control applied to the supplier and the purchased product dependant upon the effect of the purchased product on subsequent product realization or the final product?

  • AS9100C - Is the organization responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer?

  • Does the organization evaluate and select suppliers based on their ability to supply product iaw the organization’s requirements?

  • Is the criterion for selection, evaluation, & re-evaluation (of suppliers) established?

  • Are the records of the results of evaluations & any necessary actions arising from the evaluation maintained?

  • AS9100C - Note: One factor that can be used during supplier selection & evaluation is supplier quality data from objective and reliable external sources, as evaluated by the organization (e.g., information from accredited quality management system or process certification bodies, organization approvals from government authorities). Use of such data would be only one component of an organization supplier control process and the organization remains responsible for verifying that purchased product meets specified purchase requirements.

  • AS9100C - Does the organization:

  • AS9100C - a) maintain a register of its suppliers that includes approval status (e.g., approved, conditional, disapproved) and the scope of the approval (e.g., product type, process family),

  • AS9100C - b) periodically review supplier performance; are results of these reviews used as a basis for establishing the level of controls to be implemented,

  • AS9100C - c) define the necessary actions to take when dealing with suppliers that do not meet requirements,

  • AS9100C - d) ensure when required that both the organization and all suppliers use customer-approved special process sources,

  • AS9100C - 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 supplier’s approval status, and

  • AS9100C - f) determine and manage the risk when selecting and using suppliers? (see 7.1.2)

7.4.2 Purchasing Information

  • Does purchasing information describe the product to be purchased, including where appropriate:<br><br>

  • a) requirements for approval of: <br><br>products? procedures? processes? and equipment?

  • b) requirements for qualification of personnel?

  • c) quality management system requirements?

  • AS9100C - d) the identification and revision status of specification, drawings, process requirements, inspection/verification instructions and other relevant technical data,

  • AS9100C - 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 organi-zation, and as applicable critical items including key characteristics<br><br>

  • AS9100C - f) requirements for test specimens (e.g., production methods, number, storage conditions) for design approval, inspection/ verification, investigation or auditing,<br>

  • AS9100C - g) requirements regarding the need for the supplier to:<br><br>notify the organization of nonconforming product, <br><br>obtain organization approval for noncom-forming product disposition,<br><br>notify the organization of changes in product and/ or process, changes of suppliers, changes in manufacturing facility location and, where required, obtain organization approval, and<br><br>flow down to the supply chain the applicable requirements including customer requirements,<br><br><br>

  • AS9100C - h) records retention requirements, and

  • AS9100C - i) right of access by the organization, their customer and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records.

  • Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier?

7.4.3 Verification of Purchased Product

  • Has the organization established and implemented the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?<br>

  • AS9100C - NOTE 1 Customer verifyication activities performed at any level of the supply chain should not be used by the organization or the supplier as evidence of effective control of quality and does not absolve the organization of its responsebility to provide acceptable product and comply with all requirements.

  • AS9100C - NOTE 2 Verification activities can include:<br><br>> obtaining objective evidence of the conformity of the product from the supplier (e.g., accompanying documentation, certificate of conformity, test records, statistical records, process control records),<br><br>> inspection and audit at the supplier’s premises,<br><br>> review of the required documentation,<br><br>> inspection of products upon receipt, and<br><br>> delegation of verification to the supplier or supplier certification

  • AS9100C - Where purchased product is released for production use pending completion of all required verification activities, are they identified and recorded to allow recall and replacement if it is subsequently found that the product does not meet requirements?

  • AS9100C - When the organization delegates verification activities to the supplier, are the requirements for delegation defined and a register of delegation maintained?

  • Where the organization or its customer intends to perform verification at the suppliers’ premises, does the organization state the intended verification arrangements & method of product release in the purchasing information?

7.5.1 Control of Production & Service Provision

  • How does the organization plan & carry out production & service provision under controlled conditions?

  • Does (the organization’s) controlled conditions include as applicable:

  • a) The availability of informa-tion that describes the characteristics of the product?<br><br>> Note: This information can include drawings, parts lists, materials & process specifications

  • b) the availability of work instructions, as necessary?<br><br>> AS9100C Note: Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards) and inspecttion documents.

  • c) use of suitable equipment?<br><br>> AS9100C Note: Suitable equipment an include product specific tools (e.g., jigs, fixtures, and molds) and software programs.

  • d) the availability and use of monitoring and measuring equipment?

  • e) the implementation of monitoring & measurement?

  • f) The implementation of product release, delivery and post-delivery activities?

  • AS9100C - g) accountability for all product during production (e.g., parts quantities, split orders, nonconforming product),<br>

  • AS9100C - h) evidence that all production and inspection /verification operations have been completed as planned, or as otherwise documented and authorized,<br>

  • AS9100C - i) provision for the prevention, detection and removal of foreign objects,<br>

  • AS9100C - j) monitoring and control of utilities and supplies (e.i., water, compressed air, electricity, chemical products) to the extent they effect conformity to product requirements, and

  • AS9100C - k) criteria for workmanship, specified in the clearest practical way (e.g., written standards, representative samples, illustrations).

  • AS9100C - Planning shall consider, as appropriate:<br><br>

  • AS9100C - establishing, implementing and maintaining appropriate processes to manage critical items, including process controls where key characteristics have been identified,<br>

  • AS9100C - designing, manufacturing and using tooling to measure variable data,<br>

  • AS9100C - Identifying in-process inspection/verification points when adequate verification of conform-ance cannot be performed at later stages of realization, and<br>

  • AS9100C - Special processes (see 7.5.2). AS9100C - Production Process Verification

  • AS9100C - Does the organization use 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?<br>

  • AS9100C - Is this process repeated when changes occur that invalid-date the original results (e.g., engineering changes, manufacturing process changes, tooling changes).<br><br>> Note: This activity is often referred to as first article inspection. AS9100C - Control of Production Process Changes

  • AS9100C - Are personnel authorized to approve changes to production processes identified?<br>

  • AS9100C - Does the organization control & document changes affecting processes, production equipment, tools or software programs? <br>

  • AS9100C - Are the results of changes to production processes assessed to confirm that the desired effect has been achieved without adverse effects to product conformity? AS9100C - Control of Production Equipment, Tools, & Software Programs

  • AS9100C - How does the organization validate production equipment, tools & software programs used to automate & control/ monitor product realization processes, prior to release for production and how is this maintained?<br><br>

  • AS9100C - How has the organization defined storage requirements, including periodic preservation / condition checks, for production equipment or tooling in storage? AS9100C - Post Delivery Support

  • AS9100C - Is post delivery support provided as applicable for:<br>

  • AS9100C - a) collection & analysis of in-service data?<br>

  • AS9100C - b) actions to be taken, including investigations & reporting when problems are detected after delivery?<br>

  • AS9100C - c) control and updating technical documentation?<br>

  • AS9100C - d) approval, control and use of repair schemes?, and<br>

  • AS9100C - e) controls requirements for off-site work (e.g., organization’s work undertaken at the customer’s facilities)?

7.5.2 Validation of processes for production and service provision

  • Does the organization validate any processes for production & service provision where the resulting output cannot be verified by subsequent monitoring or measurement &, as a consequence, any deficiencies made apparent only after the product is in use or the service has been delivered?

  • AS9100C - Note: These processes are often referred to as Special Processes.

  • Has the organization’s validation demonstrated the ability of these processes to achieve planned results?

  • Has the organization established arrangement for these processes including, as applicable:,<br>

  • a) defined criteria for review & approval of the processes to achieve planned results?

  • b) approval of equipment and qualification of personnel?

  • c) use of specific methods & procedures?

  • d) requirements for records (see 4.2.4)?, and

  • e) revalidation?

7.5.3 Identification and traceability

  • Has the organization identified, where appropriate, the product by suitable means throughout production realization?

  • AS9100C - Does the organization maintain the identification of the configuration of the product in order to identify any differences between the actual configuration and the agreed configuration?

  • Does the organization identify product status with respect to its monitoring & measurement requirements throughout product realization?

  • AS9100C - When acceptance authority media are used (e.g., stamps, electronic signatures, passwords), has the organization established appropriate controls for the media?

  • Does the organization control & record the unique identification of the product, where traceability is a requirement? (see 4.2.4)

  • AS9100C - Note: Traceability requirements can include identification to be maintained throughout the product life, 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)<br><br>

  • AS9100C - Note: For an assembly, the ability to trace its component to the assembly and then to the next higher assembly, and<br>For a product, a sequential record of its production (manufacture, assembly, inspection/ verification) to be retrievable.

  • Note: In some industry sectors, configuration management is a means by which identification and traceability are maintained.<br><br>AS9100C - (see 7.1.3)

7.5.4 Customer property

  • How does the organization exercise care with customer property while it is under the organization’s control or being used by the organization?<br>

  • Does the organization identify, verify, protect & safeguard customer property provided for use, report this to the customer & maintain records? (see 4.2.4)

  • Does the process/procedure ensure that any customer property that is lost, damaged or otherwise found to be unsuitable for use is reported to the customer?

  • Note: Customer property can also include intellectual property and personal data.

7.5.5 Preservation of product

  • What are the processes/ procedures established by the organization to preserve the conformity of the product during internal processing and delivery to the intended destination in order to maintain conformity to the requirements?

  • Do these processes/procedures include:<br>

  • a) Product identification? <br>

  • b) Product handling?<br>

  • c) Product packaging?<br>

  • d) Product storage?<br>

  • e) Product protection?

  • Does preservation also apply to the constituent parts of a product also?

  • AS9100C - Does preservation of the product also include, where applicable iaw product specifications and applicable statutory & regulatory requirements, provisions for:<br>

  • AS9100C - a) cleaning?

  • AS9100C - b) prevention, detection & removal of foreign objects?

  • AS9100C - c) special handling for sensitive products?

  • AS9100C - d) marking & labeling including safety warnings?<br>

  • AS9100C - e) shelf life control & stock rotation? and

  • AS9100C - f) special handling for hazardous materials?

7.6 Control of monitoring and measuring equipment

  • Has the organization determined the monitoring & measurements to be undertaken?

  • The measuring, the monitoring, and measuring equipment needed to provide evidence of conformity of product to determined requirements?

  • AS9100C - Does the organization maintain a register of the monitoring & measuring equipment.

  • Define the process employed for their calibration/verification including details of equipment type, unique identification, location, frequency of checks, check method & acceptance criteria?

  • AS9100C - NOTE: Monitoring & measuring equipment includes, but is not limited to: test hardware, test software, automated test equipment (ATE) & plotters used to produce inspection data. It also includes personally owned & customer supplied equipment used to provide evidence of product conformity.

  • Does the organization have an established process to ensure that monitoring and measurement can be carried out and is carried out in a manner that is consistent with the monitoring & measurement requirements?

  • AS9100C - Does the organization ensure that environmental conditions are suitable for the calibration, inspection, measurement & testing being carried out?

  • Where necessary to ensure valid results, is the measuring equipment:<br>

  • a) calibrated or verified, or both, at specific intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded? (see 4.2.4)<br>

  • b) adjusted or re-adjusted as necessary?

  • c) identified in order to determine its calibration status?

  • d) safeguarded from adjustments that would invalidate the measurement results?

  • e) protected from damage & deterioration during handling, maintenance & storage?

  • AS9100C - Has the organization established, implemented & maintained a process for the recall of monitoring & measuring equipment requiring calibration or verification?

  • Has the organization:<br>

  • a) Assessed & recorded the validity of previous measuring results when the equipment is found not to conform to requirements?<br>

  • b) Taken appropriate action on the equipment & any product affected?

  • Are records of the results of calibrations & validations maintained? (4.2.4)

  • When used in the monitoring & measurement of specified requirement, does the organization have the ability of computer software to satisfy the intended application, & how is this confirmed? <br><br>> This shall be undertaken prior to initial use & reconfirmed as necessary.

  • Note: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification & configuration management to maintain its suitability for use.


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