AS9100 Rev C - ISO9001:2008 Internal Audit Clause 8

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

Audit Preparation

• Review corrective actions for previous IA findings

  Yes

  No

  N/A

• Review corrective actions for previous EA findings

  Yes

  No

  N/A

• Review corrective actions for any customer complaints

  Yes

  No

  N/A

• Review corrective actions for any customer audit findings

  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

• AS9100C - Note: According to the nature of the product & depending on the specified requirements, statistical techniques can be used to support:

  Yes

  No

  N/A

• a) design verification (e.g., reliability, maintainability, safety),

  Yes

  No

  N/A

• Process control:,

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• b) Process capability measurements,<br>

  Yes

  No

  N/A

• c) Statistical process control,<br>

  Yes

  No

  N/A

• d) Design of experiment,<br> > Inspection, and<br> > Failure mode, effect & criticality analysis.

  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

• Note: Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims & dealer reports.

  Yes

  No

  N/A

8.2.2 Internal Audit

• Does the organization conduct internal audits at planned intervals to determine whether the quality management system:<br>

  Yes

  No

  N/A

• a) conforms to the planned arrangements (se 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization? and<br>

  Yes

  No

  N/A

• b) 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, frequency & methods defined?<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 audit plan ensure auditors do not audit their own work?

  Yes

  No

  N/A

• Is the organization’s documented procedure established to define:<br>(see 4.2.4)

  Yes

  No

  N/A

• a) responsibilities & requirements for planning and conducting audits?<br>

  Yes

  No

  N/A

• b) responsibilities & requirements for establishing records & reporting the results of the audits?<br>

  Yes

  No

  N/A

• c) responsibilities & requirements to maintaining records?

  Yes

  No

  N/A

• Does the management responsible for the area being audited ensure that any necessary corrections & corrective actions are taken without undue delay to eliminate detected non-conformities & their causes?<br>

  Yes

  No

  N/A

• Do follow-up activities include the verification of the actions taken, and the reporting of verification results. (see 8.5.2)

  Yes

  No

  N/A

8.2.3 Monitoring and measurement of processes

• Has the organization applied suitable methods for monitoring and, where applicable, measuring the quality management system processes?

  Yes

  No

  N/A

• 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, as appropriate?

  Yes

  No

  N/A

• Note: When determining suitable methods, has the organization considered the type & extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements & on the effectiveness of the quality management system?

  Yes

  No

  N/A

• AS9100C - In the event of process nonconformity, has the organization:<br><br>(see 8.3)

  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

• Has the organization established appropriate stages in the product realization process iaw the planned arrangements (see 7.1)?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• AS9100C - Does the organization document measurement requirements for product acceptance which include:<br><br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• c) required records of the measurements results (at a minimum, indication of acceptance or rejection), and

  Yes

  No

  N/A

• AS9100C - d) any specific measurement instruments required & any specific instructions associated with their use?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• AS9100C - When the organization uses sampling inspection as means of product acceptance, is the sampling plan justified on the basis of recognized statistical principles & appropriate for use (i.e., matching the sampling plan to the criticality of the product & to the process capability?

  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

• Do the records indicate the person(s) authorizing release of 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 and service delivery 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

• Is there a documented procedure established to define the controls & related responsibilities & authorities for dealing with nonconforming product?

  Yes

  No

  N/A

• AS9100C - Note: The term “nonconforming product” includes nonconforming product returned by the customer.

  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

• c) by taking action to preclude its original intended use or application?

  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

• d) suppliers (see 7.4)

  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

• AS9100C - g) flowing down corrective action requirements to a supplier when it is determined that the supplier is responsible for the, nonconformity,<br><br>

  Yes

  No

  N/A

• AS9100C - h) specific action where timely and/or effective corrective actions are not achieved, and

  Yes

  No

  N/A

• AS9100C - i) determining if additional nonconforming product exists based on the causes of the nonconformities & taking further action when required.

  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 <<<<