8. Measurement, Analysis and Improvement

8.1 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, and
• to continually improve the effectiveness of the quality management system.

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

8.2 Monitoring and Measurement

8.2.1 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 CustomerSurveyProcess )

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

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.

8.2.2 Internal Audits

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

• conforms to the planned arrangements (see 7.1), to the requirements of AS9100 and ISO9001:2008 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 4.2.4).

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 (see 8.5.2).

Detailed tools and techniques are developed such as check sheets, process flowcharts, or similar method to support audit of the quality management system requirements. The acceptability of selected tools is measured against the effectiveness of the internal audit process and overall organization performance.

Internal audits also meet contract and/or regulatory requirements.

Supporting Documentation:

• Internal Audit Process

8.2.3 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 procedure.(see 8.3)

8.2.4 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 7.1). 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 7.1) 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.

8.2.4.1 Inspection documentation

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.

8.2.4.2 First Article Inspection:

The organization's system provides a process for the inspection, verification, and documentation of a representative item from the first production run of a new part, or following any subsequent change that invalidates the previous first article inspection result.

Supporting Documentation

• Inspection Process Flowchart, QC FAI Instruction

8.3 Control of Nonconforming Product

The organization ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure is established to define the controls and related responsibilities and authorities for dealing with nonconforming products. The term "nonconforming product" includes nonconforming product returned from a customer.

The documented procedure (Control of Nonconforming Product) defines the responsibility for review and authority for the disposition of nonconforming product and the process approving personnel making these decisions.

Where applicable, the organization deals with nonconforming product by one or more of the following ways:

• by taking action to eliminate the detected nonconformity,
• by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer, and
• by taking action to preclude its original intended use or application.
• by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

Disposition of nonconforming product is limited to:

• Scrap: Products dispositioned for scrap is conspicuously and permanently marked, or positively controlled, until physically rendered unusable (see Scrap Procedure)
• Rejection for return to supplier,
• Rejection for revalidation by the manufacturer,
• Submittal to design authority and customer for "Use-As-Is" disposition.

The organization does not use dispositions of use-as-is or repair, unless specifically authorized by the customer,

• if the product is produced to customer design, or
• the nonconformity results in a departure from the contract requirements
• if applicable, unless otherwise restricted in the contract, organization-designed product which is controlled via a customer specification is dispositioned by the organization as use-as-is or repair, provided the nonconformity does not result in a departure from customer-specified requirements.

When nonconforming product is corrected the product is subject to re-verification to demonstrate conformity to the requirements.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, are maintained (see 4.2.4)

When nonconforming product is detected after delivery or use has started, appropriate actions are taken to the effects or potential effects of the nonconformity.

In addition to any contract or regulatory authority reporting requirements, the organization provides for timely reporting of delivered nonconforming product that may affect reliability or safety. Notification includes a clear description of the nonconformity, which includes as necessary parts affected, customer and/or organization part numbers, quality, and date(s) delivered.

Note: Parties requiring notification of nonconforming product may include suppliers, internal organizations, customers, distributors, and regulatory authorities.

Supporting Documentation

• Control of Nonconforming Product
• Non Conforming Material Process Flowchart
• Nonconforming Material Due to Revision Change
• Scrap Procedure

8.4 Analysis of data

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 8.2.1),
• conformity to product requirements (see 8.2.4),
• characteristics and trends of processes and products, including opportunities for preventive action (see 8.2.3 and 8.2.4), and
• suppliers (see 7.4).

Supporting Documentation:

• Internal Audit Process
• Non Conforming Material Process Flowchart
• Performance Measurement Process

8.5 Improvement

8.5.1 Continual improvement

The organization continually improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews.

Supporting Documentation:

• Performance Measurement Process

8.5.2 Corrective action

The organization takes action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered.

A documented procedure is established to define requirements for:

• reviewing nonconformities (including customer complaints),
• determining the causes of nonconformities,
• evaluating the need for action to ensure that nonconformities do not recur,
• determining and implementing action needed,
• records of the results of action taken (see 4.2.4), and
• reviewing the effectiveness of the corrective action taken.
• flow down of the corrective action requirement to a supplier, when it is determined that the supplier is responsible for the root cause, and
• specific actions where timely and/or effective corrective actions are not achieved.

Supporting Documentation

• CorrectivePreventiveActionProcedure
• CorrectivePreventiveActionFlowchart
• Management Action Request Form
• Supplier Corrective Action Request Form
• Root Cause Analysis

8.5.3 Preventive action

The organization determines actions to eliminate the cause of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems. When anticipated, a documented procedure is established to define requirements for:

• determining potential nonconformities and their causes,
• evaluating the need for action to prevent occurrence of nonconformities,
• determining and implementing action needed,
• records of results of action taken (see 4.2.4), and
• reviewing the effectiveness of the preventive action taken,
• the withdrawal of product(s) from stock that are suspected of a noncompliance, including notification of customer of the actions taken who have purchased the product from the same lot.

Supporting Documentation

• Corrective/Preventive Action Procedure
• Corrective/Preventive Action Flowchart
• Management Action Request Form
• Supplier Corrective Action Request Form

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