AS9120 Rev B - ISO9001:2015 Process Audit Design exempt.

• Audit Title

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

4.1 General Requirements

• Has the organization established, documented, implemented and maintained a quality management system?<br>

  Yes

  No

  N/A

• Has the organization determined external and internal issues relevant to its purpose and strategic direction?

  Yes

  No

  N/A

4.2.1 Documentation Requirements - General

• Does the documentation include documented statements of a quality policy and quality objectives?<br>

  Yes

  No

  N/A

• Has the organization ensured that personnel have access to, and are aware of, relevant quality management system documentation & changes?

  Yes

  No

  N/A

4.2.2 Quality Manual

• Has the quality manual been established?<br>

  Yes

  No

  N/A

• Is the quality manual maintained?<br>

  Yes

  No

  N/A

• The scope of the quality management system including details of and justification for any exclusions (see 1.2)?

  Yes

  No

  N/A

• a description of the interaction between the processes of the quality management system?<br>

  Yes

  No

  N/A

4.2.3 Control of Documents

• Are all documents required by the quality management system controlled?<br>

  Yes

  No

  N/A

• Has a documented procedure been established to define the controls needed to approve documents for adequacy prior to issue and subsequent up revision<br>

  Yes

  No

  N/A

• to review and update as necessary and re-approve documents?<br>

  Yes

  No

  N/A

• to ensure that changes and the current revision status of documents are identified?<br>

  Yes

  No

  N/A

• to ensure that relevant versions of applicable documents are available at points of use?<br>

  Yes

  No

  N/A

• to ensure that documents remain legible and readily identifiable?<br>

  Yes

  No

  N/A

4.2.4 Control of Records

• Have records been established to provide evidence of conformity to requirements and of the effective operation of the quality management system?<br>

  Yes

  No

  N/A

• Has a documented procedure been established to define the controls needed for the identification of records?

  Yes

  No

  N/A

• Are they controlled?<br>

  Yes

  No

  N/A

• Storage of records?<br>

  Yes

  No

  N/A

• Protection of records?<br>

  Yes

  No

  N/A

• Retrieval of records?<br>

  Yes

  No

  N/A

• retention time of records? Minimum 10 years <br>

  Yes

  No

  N/A

• Are records legible?<br>

  Yes

  No

  N/A

5.1 Management Commitment

• Is there evidence of commitment by top management toward the development, implementation and improvement of the quality management system and continually improving its effectiveness by:

  Yes

  No

  N/A

• a) communicating to the organization the importance of meeting customer’s, statutory and regulatory requirements?<br><br><br><br>

  Yes

  No

  N/A

5.2 Customer Focus

• Does top management ensure that customer requirements are determined?<br>

  Yes

  No

  N/A

• Does top management ensure that customer requirements are met?<br>

  Yes

  No

  N/A

• Is this with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1)?<br>

  Yes

  No

  N/A

• How does top management ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not, or will not be achieved?

  Yes

  No

  N/A

5.3 Quality Policy

• How has top management ensured that the quality policy:

  Yes

  No

  N/A

• c) provide a framework for establishing and reviewing quality objectives?

  Yes

  No

  N/A

5.4 Planning

5.4.1 Quality Objectives

• How has top management ensured that quality objectives, including those needed to meet requirements for product (see 7.1a), are established at relevant functions & levels within the organization? Quality objectives shall be measurable and consistent with the quality policy.

  Yes

  No

  N/A

• Are the quality objectives measurable?<br>

  Yes

  No

  N/A

• Are the quality objectives consistent with the quality policy?<br>

  Yes

  No

  N/A

5.4.2 Quality Management System Planning

• Does top management ensure that:<br>

  Yes

  No

  N/A

• a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?

  Yes

  No

  N/A

• b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?<br>

  Yes

  No

  N/A

5.5.1 Responsibility and Authority

• Has the organisation an organisation chart which defines roles and responsibilities and authorisations<br>

  Yes

  No

  N/A

5.5.2 Management Representative

• Has top management appointed a member of its management:

  Yes

  No

  N/A

• AS9100C - d) the organizational freedom and unrestricted access to top management to resolve quality management issues?

  Yes

  No

  N/A

5.5.3 Internal Communication

• How does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness if the quality management system?

  Yes

  No

  N/A

5.6.1 Management Review - General

• Does the top management review the organization’s quality management system, at planned intervals, to ensure its continuing stability, adequacy and effectiveness?

  Yes

  No

  N/A

• Does this reviews include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy & objectives?

  Yes

  No

  N/A

• Are records from management reviews maintained? (see 4.2.4)

  Yes

  No

  N/A

5.6.2 Review Input

• Does management review inputs including:

  Yes

  No

  N/A

• Results of audits?<br>

  Yes

  No

  N/A

• Process performance and product conformity?<br>

  Yes

  No

  N/A

• Status of preventive and corrective actions?<br>

  Yes

  No

  N/A

• Follow-up actions from previous management reviews?<br>

  Yes

  No

  N/A

• Changes which could effect the quality management system?<br>and

  Yes

  No

  N/A

• Recommendations for improvement?<br>

  Yes

  No

  N/A

5.6.3 Review Output

• Does the output from management reviews include decisions & actions related to:

  Yes

  No

  N/A

• a) Improvements to the quality management system and its processes?<br>

  Yes

  No

  N/A

• b) Improvements to product related to customer requirements?<br>

  Yes

  No

  N/A

• c) TImesales and owners for actions<br>

  Yes

  No

  N/A

6.1 Provision of Resources

• Has the organization determined and provided the resources needed:

  Yes

  No

  N/A

• a) to implement and maintain the quality management system & continually improve its effectiveness?

  Yes

  No

  N/A

• b) to enhance customer satisfaction by meeting customer requirements?

  Yes

  No

  N/A

6.2.1 Human Resources - General

• How does the organization determine personnel performing work affecting conformity to product requirements are competent on the basis of appropriate education, training, skills and experience?

  Yes

  No

  N/A

6.2.2 Competence, Awareness & Training

• How has the organization:<br>

  Yes

  No

  N/A

• a) determined the necessary competency for personnel performing work affecting conformity to product requirements?

  Yes

  No

  N/A

• b) where applicable, provided training or taken other actions to achieve the necessary competence?

  Yes

  No

  N/A

• c) evaluated the effectiveness of the action(s) taken?

  Yes

  No

  N/A

• e) maintained appropriate records of education, training, skills & experience (see 4.2.4)

  Yes

  No

  N/A

6.3 Infrastructure

• How does the organization determine, provided and maintain the infrastructure needed to achieve conformity to product requirements? Infrastructure includes, as applicable:

  Yes

  No

  N/A

• a) Buildings, workspace and associated utilities,

  Yes

  No

  N/A

6.4 Work Environment

• Has the organization determined and managed the work environment needed to achieve conformity to product requirements?

  Yes

  No

  N/A

7. Product Realization

7.1 Planning of Product Realization

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

  Yes

  No

  N/A

• a) Quality objectives and requirements for the product?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• c) verification, validation, monitoring, measurement, inspection and test activities specific to the product

  Yes

  No

  N/A

• records are needed to provide <br>

  Yes

  No

  N/A

• 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>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• e) Selection & development of embedded software,

  Yes

  No

  N/A

• c) Producibility & inspectability,

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

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:

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.1.3 Configuration Management

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

  Yes

  No

  N/A

• AS9100C - a) configuration management planning

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• AS9100C - c) change control

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

7.2.3 Customer Communication

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

  Yes

  No

  N/A

• a) Product information?<br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.4.1 Purchasing Process

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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),

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.4.2 Purchasing Information

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• AS9100C - e) Where applicable 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 identification of critical items including key characteristics<br><br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• How. does the organization flow down the requirements to the supplier including customer specifics

  Yes

  No

  N/A

7.4.3 Verification of Purchased Product

• Has the organization established a goods receiving and verification of products purchased<br>

  Yes

  No

  N/A

• AS9100C - Where product is released for production has traceability been established

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.5.1 Production

• How does the supply control production during realisation activities (example route cards)

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• AS9100C - Identifying in-process inspection/verification points when verification of conformance cannot be performed at later stages of manufacturing.<br>

  Yes

  No

  N/A

• AS9100C - Special processes (see 7.5.2).

  Yes

  No

  N/A

7.5.1.1 AS9100C - Production Process Verification

• AS9100C - Are FAI completed in accordance with AS9102 Rev B<br>

  Yes

  No

  N/A

7.5.1.2 AS9100C - Control of Production Process Changes

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.5.1.3 AS9100C - Control of Production Equipment, Tools, & Software Programs

• AS9100C - How does the organization validate production equipment and software and control changes in software programme<br><br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.5.1.4 AS9100C - Post Delivery Support

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

  Yes

  No

  N/A

• AS9100C - notification to customer if non conformity detected which can effect customer<br>

  Yes

  No

  N/A

• AS9100C - approval, control and use of repair schemes approved by customer prior to commencement of rework.<br>

  Yes

  No

  N/A

7.5.2 Special process

• How 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• b) approval of equipment and qualification of personnel?

  Yes

  No

  N/A

• c) use of specific methods & procedures?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.5.3 Identification and traceability

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

  Yes

  No

  N/A

• 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?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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?

  Yes

  No

  N/A

• Do these processes/procedures include:<br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Product handling?<br>

  Yes

  No

  N/A

• Product storage?<br>

  Yes

  No

  N/A

• Product protection?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• AS9100C - c) special handling for sensitive products?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

7.6 Control of monitoring and measuring equipment

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

  Yes

  No

  N/A

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

  Yes

  No

  N/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>

  Yes

  No

  N/A

• identified in order to determine its calibration status?

  Yes

  No

  N/A

• process for the recall of monitoring & measuring equipment requiring calibration or verification?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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.

  Yes

  No

  N/A

8.1 Measurement, analysis and improvement - General

• Has the organization planned & implemented monitoring, measurement, analysis and improvement processes needed:<br>

  Yes

  No

  N/A

• a) to demonstrate conformity to product requirements?<br>

  Yes

  No

  N/A

• b) to ensure conformity of the quality management system? <br>

  Yes

  No

  N/A

• c) to continually improve the effectiveness of the quality management system? <br>

  Yes

  No

  N/A

• Does this include determine-ation of applicable methods, including statistical techniques, & the extent of their use?

  Yes

  No

  N/A

• Process control:,

  Yes

  No

  N/A

• Selection & inspection of key characteristics,<br><br>

  Yes

  No

  N/A

8.2.1 Customer satisfaction

• As one of the measurements of the performance of the quality management system, does the organization monitor information relating to customer perception as to whether the organization has met customer requirements? <br><br><br>Are organizational methods to obtain & using this information determined?

  Yes

  No

  N/A

• AS9100C - Does the information to be monitored & used for the evaluation of customer satisfaction include, but is not limited to, product conformity, on-time delivery performance, customer complaints and corrective action requests?

  Yes

  No

  N/A

• AS9100C - Has the organization developed & implemented plans for customer satisfaction improvement that address deficiencies identified by these evaluations, & assessed the effectiveness of the results?

  Yes

  No

  N/A

8.2.2 Internal Audit

• Does the organization conduct internal audits at planned intervals ?<br>

  Yes

  No

  N/A

• Is effectively implemented & maintained

  Yes

  No

  N/A

• AS9100C - Do planned arrangements include customer contractual requirements?<br>

  Yes

  No

  N/A

• Is the audit program planned, taking into consideration the status & importance of the processes & areas to be audited, as well as the results of previous audits?

  Yes

  No

  N/A

• Is the audit criteria, scope and frequency ?<br>

  Yes

  No

  N/A

• Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?

  Yes

  No

  N/A

• Does the organisation allocate the closures of non conformities to the responsible manager for timely closure <br><br>

  Yes

  No

  N/A

• Is there evidence of follow-up activities include the verification of the actions taken (see 8.5.2)

  Yes

  No

  N/A

8.2.3 Monitoring and measurement of processes

• Do these methods demonstrate the ability of the process to achieve planned results?

  Yes

  No

  N/A

• When planned results are not achieved, are corrections and corrective actions taken.?

  Yes

  No

  N/A

• a) taken appropriate action to correct the nonconforming process?<br>

  Yes

  No

  N/A

• b) evaluated whether the process nonconformity has resulted in product nonconformity, <br>

  Yes

  No

  N/A

• c) determined if the process nonconformity is limited to a specific case or whether is could have affected other processes or product, and<br>

  Yes

  No

  N/A

• d) identified and controlled any nonconforming product?<br>

  Yes

  No

  N/A

8.2.4 Monitoring and measurement of product

• Does the organization monitor & measure product characteristics to verify that product requirements have been met?

  Yes

  No

  N/A

• Does the organization maintain evidence of conformity with the acceptance criteria?

  Yes

  No

  N/A

• criteria for acceptance and/or rejection?<br>

  Yes

  No

  N/A

• where in the sequence measurement & testing operations are to be performed?<br>

  Yes

  No

  N/A

• required records of the measurements results including where applicable testing and verification

  Yes

  No

  N/A

• AS9100C - When critical items, including key characteristics have been identified, does the organization ensure they are controlled & monitored.?

  Yes

  No

  N/A

• AS9100C - When the organization uses sampling inspection as verification IS the plan to international standard (AQL)

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• List of personnel who can release the product for delivery to the customer? (see 4.2.4)

  Yes

  No

  N/A

• AS9100C - Where required to demonstrate product qualification, has the organization ensured that records provide evidence that the products meets the defined requirements?

  Yes

  No

  N/A

• Does the organization hold up product release until planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.)?

  Yes

  No

  N/A

• AS9100C - Does the organization ensure that all documents required to accompany the product are present at delivery?

  Yes

  No

  N/A

8.3 Control of nonconforming product

• Does the organization ensures that product which does not conform to product requirements is identified and controlled to prevented its unintended use or delivery?<br>

  Yes

  No

  N/A

• AS9100C - Does the organization’s documented procedure define the responsibilities & authority for the review & disposition of nonconforming product, & the process for approving personnel making these decisions?

  Yes

  No

  N/A

• Where applicable, does the organization deal w/ noncom-forming product by one or more of the following ways?:<br>

  Yes

  No

  N/A

• a) by taking action to eliminate the detected nonconformity?<br>

  Yes

  No

  N/A

• b) by authorized its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer?<br>

  Yes

  No

  N/A

• d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?

  Yes

  No

  N/A

• AS9100C - Does the organization’s nonconforming product control process provide for timely reporting of delivered nonconforming product?

  Yes

  No

  N/A

• AS9100C - Note: Parties requiring notification of nonconforming product can include suppliers, internal organizations, customers, distributors & regulatory authorities.

  Yes

  No

  N/A

• AS9100C - e) by taking action necessary to contain the effect of the nonconformity on other processes or products?

  Yes

  No

  N/A

• AS9100C - Does the organization have procedures in place to ensure that dispositions of USE AS IS or REPAIR shall only be used after approval by an authorized representative of the organization responsible for the design?

  Yes

  No

  N/A

• AS9100C - Note: Authorized representative includes personnel having delegated authority from the design organization.<br>The organization shall not use dispositions of USE AS IS or REPAIR, unless specifically authorized by the customer, if the nonconformity results in a departure from the contract requirements.

  Yes

  No

  N/A

• AS9100C - Is product dispositioned for SCRAP conspicuously & permanently marked, or positively controlled, until physically rendered unusable?

  Yes

  No

  N/A

• When nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements?

  Yes

  No

  N/A

• Does the organization have a process to maintain records of the nature of nonconformities & any subsequent actions taken, including concessions obtained? (see 4.2.4)

  Yes

  No

  N/A

8.4 Analysis of data

• Has the organization deter-mined, collected & analyzed appropriate data to demon-strate the suitability and effectiveness of the quality management system & to evaluate where continual improvement of the effective-ness of the quality manage-ment system can be made?

  Yes

  No

  N/A

• Does this include data generated as a result of monitoring & measurement & from other relevant sources?<br>

  Yes

  No

  N/A

• Does organization’s analysis of data provide information relating to:

  Yes

  No

  N/A

• a) customer satisfaction? (see 8.2.1)<br>

  Yes

  No

  N/A

• b) conformity to product requirements? (see 8.2.4)<br>

  Yes

  No

  N/A

• c) Characteristics & trends of process & products, including opportunities for preventive action? (see 8.2.3 & 8.2.4), and

  Yes

  No

  N/A

• Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data,?

  Yes

  No

  N/A

8.5.1 Continual improvement

• Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of:<br>

  Yes

  No

  N/A

• a) Quality policy?<br><br>

  Yes

  No

  N/A

• b) Quality objectives?<br><br>

  Yes

  No

  N/A

• c) Audit results?<br><br>

  Yes

  No

  N/A

• d) Analysis of data?<br><br>

  Yes

  No

  N/A

• e) Corrective & preventive action?<br><br>

  Yes

  No

  N/A

• f) Management review?

  Yes

  No

  N/A

• AS9100C - Does the organization monitor the implementtation of improvement activities & evaluate the effectiveness of the results?

  Yes

  No

  N/A

• AS9100C - Note: Continual improvement opportunities can result from lessons learned, problem resolutions & the benchmarking of best practices.

  Yes

  No

  N/A

8.5.2 Corrective action

• Has the organization taken action to eliminate the causes of nonconformities in order to prevent recurrence? <br>

  Yes

  No

  N/A

• Are Corrective Actions appropriate to the effects of the nonconformities encountered? <br>

  Yes

  No

  N/A

• Is a documented procedure established to defined requirements for:<br>

  Yes

  No

  N/A

• a) Reviewing nonconformities (including customer complaints)?<br>

  Yes

  No

  N/A

• b) Determining the cause of nonconformities?<br>

  Yes

  No

  N/A

• c) Evaluating the need for actions to ensure that nonconformities do not recur?<br>

  Yes

  No

  N/A

• d) Determining & implementing the corrective action needed?<br>

  Yes

  No

  N/A

• e) Records of the results of action taken? (see 4.2.4)

  Yes

  No

  N/A

• f) Reviewing the effectiveness of corrective action taken?

  Yes

  No

  N/A

8.5.3 Preventive action

• Has the organization determined actions appropriate to eliminate the causes of potential nonconformities in order to prevent their occurrence?

  Yes

  No

  N/A

• Are preventive action shall be appropriate to the effects of the potential problems?

  Yes

  No

  N/A

• Has the organization estab-lished a documented procedure to define requirements for:<br>

  Yes

  No

  N/A

• a) determining potential non-conformities & their causes?

  Yes

  No

  N/A

• b) evaluating the need for actions to prevent occurrence of non-conformities?

  Yes

  No

  N/A

• c) determining and implementing action needed?

  Yes

  No

  N/A

• d) recording the results of actions taken? (see 4.2.4), and

  Yes

  No

  N/A

• e) Reviewing the effectiveness of the preventive action taken?

  Yes

  No

  N/A

• AS9100C - Note: Examples of preventive action opportunities include risk management, error proofing, failure mode and effect analysis (FMEA), & information on product problems reported by external sources.

  Yes

  No

  N/A

>>>> END OF CHECKLIST <<<<