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-- QualitySystemManual - 02 Jul 2008

9. Performance Evaluation

9.1 Monitoring, Measurement, Analysis & Evaluation

9.1.1 General

The organization plans and implements the monitoring, measurement, analysis and improvement processes needed:

  • to demonstrate conformity to product requirements,
  • to ensure conformity of the quality management system,
  • to continually improve the effectiveness of the quality management system, and
  • to ensure that Management evaluates the performance and effectiveness of the quality management system itself.

This includes determination of applicable methods, including statistical techniques, and the extent of their use. At the quality planning stage the implementation of statistical control methods are considered. These are documented in the quality plan for each job, if applicable.

Note: Depending on the specified customer requirements, statistical techniques maybe used to support:

  • design verification (e.g. reliability, maintainability, safety)
  • process control: selection and inspection of key characteristics, process capability measurements, statistical process control, design of experiment
  • inspection - matching sampling rate to the criticality of the product and to the process capability. If required by customer contract, a customer approved acceptance-sampling plan is implemented.
  • Failure mode and effect analysis
9.1.2 Customer satisfaction

As one of the measurements of the performance of the quality management system, the organization monitors information relating to customer satisfaction as to whether the organization has met customer requirements. The method for obtaining and using this information is determined. (see QualitySystem/ManagementReview.CustomerSurveyProcess )

The organization periodically reviews customer-generated quality, delivery and other satisfaction data. (see QualitySystem/ManagementReview.WebHome )

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.

9.1.3 Analysis and Evaluation

The organization determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data provides information relating to:

  • customer satisfaction (see 9.1.2),
  • conformity to product requirements,
  • characteristics and trends of processes and products, including opportunities for preventive action (see section 10), and
  • suppliers
Supporting Documentation:

9.2 Internal Audits

The organization conducts internal audits at planned intervals to determine whether the quality management system:

  • conforms to the planned arrangements (see 8.1), to the requirements of AS9100 and ISO9001:2015 and to the quality management system requirements established by the organization, and
  • is effectively implemented and maintained.

An audit program has been planned and implemented and an audit schedule has been developed based on the importance of the areas to be audited, as well as the result of previous audits. The audit criteria, scope, frequency and methods have been defined. The selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process. Auditors do not audit their own work.

A documented procedure is established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. Records of the audits and their results are maintained (see 4.2).

The management responsible for the area being audited ensures that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results.


Note for the purposes of compliance to AS9100 Rev D, the organization will follow an abbreviated schedule determined by the Quality Management Representative.

Supporting Documentation:

9.2.3 Monitoring and Measurement of Processes

The organization applies suitable methods for monitoring and where applicable, measurement of the quality management system processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action are taken, as appropriate.

Note: When determing suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.

In the event of nonconformity, the organization:

  • takes appropriate action to correct the nonconforming process.
  • evaluates with the process nonconformity has resulted in product nonconformity.
  • identifies and controls the nonconforming product in accordance with the Control of Nonconforming Product process.
9.2.4 Monitoring and Measurement of Product

The organization monitors and measures the characteristics of the product to verify that product requirements have been met. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 8.1). Evidence of conformity with the acceptance criteria is maintained.

If key characteristics are identified, they shall be monitored and controlled. If sampling inspection is required as a means of product acceptance, the sampling plan shall be statistically valid and appropriate for use. The plan precludes the acceptance of lots whose sample has known nonconformities. When required the plan is submitted for customer approval.

Product shall not be used until it has been inspected or otherwise verified as conforming to specified requirements, except (if applicable) when product is released under positive-recall procedures pending completion of all requirement and monitoring activities.

Records indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4)

The release of product and delivery of service to the customer does not proceed until the planned arrangements (see 8.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and where applicable, by the customer.

The organization established documented procedures for the inspection, verification, and documentation of a representative item from the first production run as contractually required by the customer.

Measurement requirements for product or service acceptance are documented. This documentation is a part of the production documentation, but includes

  • criteria for acceptance and/or rejection,
  • where in the sequence measurement and testing operations are performed,
  • a record of the measurement results, and
  • type of measurement instruments required and any specific instructions associated with their use.

Test records show actual results data when required by specification or acceptance test plan.

When required to demonstrate product qualification the organization ensures that records provide evidence that the product meets the defined requirements.

Supporting Documentation

9.3 Management Review

Management reviews the management system, 4 times a year, to ensure its continuing suitability, adequacy and effectiveness. The review includes assessing opportunities for improvement, and the need for changes to the management system, including the Quality Policy and quality objectives.

Management review frequency, agenda (inputs), outputs, required members, actions taken and other review requirements are defined in the documented procedure.

Records from management reviews are maintained.

Topic revision: r47 - 21 May 2019 - JohnKreis
 
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