Information
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Document No.
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Audit Title
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Client / Site
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Conducted on
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Prepared by
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Location
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Personnel
Audit Preparation
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Review corrective actions for previous IA findings
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Review corrective actions for previous EA findings
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Review corrective actions for any customer complaints
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Review corrective actions for any customer audit findings
8.1 Measurement, analysis and improvement - General
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Has the organization planned & implemented monitoring, measurement, analysis and improvement processes needed to demonstrate conformity to product requirements?<br>
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Has the organization planned & implemented monitoring, measurement, analysis and improvement processes needed to ensure conformity of the quality management system? <br>
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Has the organization planned & implemented monitoring, measurement, analysis and improvement processes needed to continually improve the effectiveness of the quality management system? <br>
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Has the organization planned & implemented monitoring, measurement, analysis and improvement processes needed to include determine-ation of applicable methods, including statistical techniques, & the extent of their use?
8.1 Measurement, analysis and improvement - Process control
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a) Selection & inspection of key characteristics,<br><br>
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b) Process capability measurements,<br>
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c) Statistical process control,<br>
8.2.1 Customer satisfaction
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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?
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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?
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Has the organization developed & implemented plans for customer satisfaction improvement that address deficiencies identified by these evaluations, & assessed the effectiveness of the results?
8.2.2 Internal Audit Planning
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Does the organization conduct internal audits at planned intervals to determine whether the quality management system 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>
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Does the organization conduct internal audits at planned intervals to determine whether the quality management system is effectively implemented & maintained
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Does the organization conduct internal audits at planned intervals to determine whether the quality management system is planned to include arrangements for customer contractual requirements?<br>
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Does the organization conduct internal audits at planned intervals to determine whether the quality management system planned, taking into consideration the status & importance of the processes & areas to be audited, as well as the results of previous audits?
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Are the organization audit criteria, scope, frequency & methods defined?<br>
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Does the organization selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?
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Does the organization audit plan ensure auditors do not audit their own work?
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Are the organization responsibilities & requirements for planning and conducting audits defined?<br>
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Are the organization responsibilities & requirements to maintaining records defined?
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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>
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Do follow-up activities include the verification of the actions taken, and the reporting of verification results. (see 8.5.2)
8.2.3 Monitoring and measurement of processes
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Has the organization applied suitable methods for monitoring and, where applicable, measuring the quality management system processes?
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Do these methods demonstrate the ability of the process to achieve planned results?
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When planned results are not achieved, are corrections and corrective actions taken, as appropriate?
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In the event of process nonconformity, has the organization (see 8.3) taken appropriate action to correct the nonconforming process?<br>
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In the event of process nonconformity, has the organization (see 8.3) evaluated whether the process nonconformity has resulted in product nonconformity, <br>
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In the event of process nonconformity, has the organization (see 8.3) determined if the process nonconformity is limited to a specific case or whether is could have affected other processes or product, and<br>
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In the event of process nonconformity, has the organization (see 8.3) identified and controlled any nonconforming product?<br>
8.2.4 Monitoring and measurement of product
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Does the organization monitor & measure product characteristics to verify that product requirements have been met?
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Has the organization established appropriate stages in the product realization process iaw the planned arrangements (see 7.1)?
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Does the organization maintain evidence of conformity with the acceptance criteria?
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Does the organization document measurement requirements for product acceptance which include - criteria for acceptance and/or rejection?<br>
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Does the organization document measurement requirements for product acceptance which include - where in the sequence measurement & testing operations are to be performed?<br>
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Does the organization document measurement requirements for product acceptance which include - required records of the measurements results (at a minimum, indication of acceptance or rejection)
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Does the organization document measurement requirements for product acceptance which include -any specific measurement instruments required & any specific instructions associated with their use?
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When critical items, including key characteristics have been identified, does the organization ensure they are controlled & monitored and the established processes?
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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?
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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?
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Do the records indicate the person(s) authorizing release of the product for delivery to the customer? (see 4.2.4)
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Where required to demonstrate product qualification, has the organization ensured that records provide evidence that the products meets the defined requirements?
8.3 Control of nonconforming product
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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>
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Is there a documented procedure established to define the controls & related responsibilities & authorities for dealing with nonconforming product?
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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?
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Where applicable, does the organization deal w/ noncom-forming product by one or more of the following ways?:<br>
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Where applicable, does the organization deal with noncom-forming product by taking action to eliminate the detected nonconformity? or<br>
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Where applicable, does the organization deal with noncom-forming product by authorized its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer? or<br>
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Where applicable, does the organization deal with noncom-forming product by taking action to preclude its original intended use or application? or
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Where applicable, does the organization deal with noncom-forming product by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?
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Where applicable, does the organization deal with noncom-forming product by taking action necessary to contain the effect of the nonconformity on other processes or products?
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Does the organization’s nonconforming product control process provide for timely reporting of delivered nonconforming product?
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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)
8.4 Analysis of data
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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?
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Does this include data generated as a result of monitoring & measurement & from other relevant sources?<br>
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Does organization’s analysis of data provide information relating to customer satisfaction? (see 8.2.1)<br>
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Does organization’s analysis of data provide information relating to conformity to product requirements? (see 8.2.4)<br>
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Does organization’s analysis of data provide information relating to Characteristics & trends of process & products, including opportunities for preventive action? (see 8.2.3 & 8.2.4), and
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Does organization’s analysis of data provide information relating to suppliers (see 7.4)
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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,?
8.5.1 Continual improvement
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Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of Quality policy?<br><br>
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Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of Quality objectives?<br><br>
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Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of Audit results?<br><br>
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Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of Analysis of data?<br><br>
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Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of Corrective & preventive action?<br><br>
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Does the organization use the following information to facilitate continual improvement of the Quality Management System through the use of Management review?
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Does the organization monitor the implementtation of improvement activities & evaluate the effectiveness of the results<br><br>Note: Continual improvement opportunities can result from lessons learned, problem resolutions & the benchmarking of best practices.
8.5.2 Corrective action
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Has the organization taken action to eliminate the causes of nonconformities in order to prevent recurrence? <br>
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Are Corrective Actions appropriate to the effects of the nonconformities encountered? <br>
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Is a documented procedure established to defined requirements for Reviewing nonconformities (including customer complaints)?<br>
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Is a documented procedure established to defined requirements for Determining the cause of nonconformities?<br>
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Is a documented procedure established to defined requirements for Evaluating the need for actions to ensure that nonconformities do not recur?<br>
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Is a documented procedure established to defined requirements for Determining & implementing the corrective action needed?<br>
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Is a documented procedure established to defined requirements for Records of the results of action taken? (see 4.2.4)
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Is a documented procedure established to defined requirements for Reviewing the effectiveness of corrective action taken?
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Is a documented procedure established to defined requirements for downstream corrective action requirements to a supplier when it is determined that the supplier is responsible for the, nonconformity,<br><br>
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Is a documented procedure established to defined requirements for:<br>specific action where timely and/or effective corrective actions are not achieved, and determining if additional nonconforming product exists based on the causes of the nonconformities & taking further action when required.
8.5.3 Preventive action
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Has the organization determined actions appropriate to eliminate the causes of potential nonconformities in order to prevent their occurrence?
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Are preventive action shall be appropriate to the effects of the potential problems?
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Has the organization estab-lished a documented procedure to define requirements for:<br>
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Has the organization estab-lished a documented procedure to define requirements for determining potential non-conformities & their causes?
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Has the organization estab-lished a documented procedure to define requirements for evaluating the need for actions to prevent occurrence of non-conformities?
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Has the organization estab-lished a documented procedure to define requirements for determining and implementing action needed?
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Has the organization estab-lished a documented procedure to define requirements for recording the results of actions taken? (see 4.2.4), and
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Has the organization estab-lished a documented procedure to define requirements for Reviewing the effectiveness of the preventive action taken?
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Assessor
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Process Owner
