Quality Manual

8. Measurement, analysis and improvement

June 6, 2006; Issue 1

8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective action
8.5.3 Preventive action

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed

1. to demonstrate conformity of the product,
2. to ensure conformity of the quality management system, and
3. to continually improve the effectiveness of the quality management system.

This shall include determination of applicable methods, including statistical techniques, and the extent of their use

8.1 General

The company has issued procedures and instructions detailing inspection and testing methods, techniques and levels for all inspection points. (QSP-0824).

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 shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

The company has methods for determining customer satisfaction as one of the measurements of the performance of the quality management system.

8.2.2 Internal audit

The organization shall conduct internal audits at planned intervals to determine whether the quality management system

1. conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
2. is effectively implemented and maintained.

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

NOTE See ISO 10011-1, ISO 10011-2 and 10011-3 for guidance.

8.2.2 Internal audit

The company has issued a procedure detailing the internal audit system (QSP-0822). There is also a Shop Audit procedure (QSP-0822A).

The system is designed to check the effectiveness of the quality system and conformance with planned activities.

Internal quality audits are carried out in accordance with a program based on status and importance of the activity.

Records of audit results are retained as a quality record (QSP-0424).

Internal quality auditors are trained and authorized to perform audits independent of their area of responsibility.

The audit results are used to test and improve the effectiveness of the system.

Corrective actions implemented to improve the system are followed up to check the effectiveness of the actions taken.

8.2.3 Monitoring and measurement of processes

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

8.2.3 Monitoring and measurement of processes

The company implements and maintains business performance measures to monitor the various processes.

Management regularly reviews the data and corrective actions are taken, when required, to achieve the desired results. (QSP-0560)

8.2.4 Monitoring and measurement of product

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.  This shall be 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 shall be maintained. Records shall

indicate the person (s) authorizing release of product (see 4.2.4).

Product release and service delivery shall 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.

8.2.4 Monitoring and measurement of product

The company has issued a procedure detailing controls for purchased product requiring receiving inspection, including type of products, and inspections required (QSP-0824)

The details of required in-process inspection testing are recorded in procedures, including requirements for segregation, reporting and control of non conforming product.

The company has prepared procedures and instructions detailing the final verification requirements. No order is dispatched until all verifications are completed and conform to specifications (QSP-0824).

All inspection and test records are designated as quality records and retained in accordance with procedure QSP-0424.

The personnel authorized to perform final inspection functions are shown in the relevant procedure.

8.3 Control of nonconforming product

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

The organization shall deal with nonconforming product by one or more of the following ways:

1. by taking action to eliminate the detected nonconformity;
2. by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
3. by taking action to provide its original intended use or application.

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

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

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.

8.3 Control of nonconforming product

A procedure controls the nonconforming material system (QSP-0830). The system provides for identification, segregation, repair/rework, re-inspection, controlled disposition, disposal and reporting.

The procedure defines documentation of customer approval prior to dispatch of product outside of contract requirements (QSP-0830).

The company issues actions to be taken when nonconforming product is detected after delivery, to contain the problem and prevent any future recurrence.

8.4 Analysis of data

The organization shall determine, collect and analyze 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 shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to

1. customer satisfaction (see 8.2.1),
2. conformity to product requirements (see 7.2.1),
3. characteristics and trends of processes and products including opportunities for preventive action, and
4. suppliers.

8.4 Analysis of data

The company has identified the collection and analysis of data, which includes

a. customer satisfaction through the monitoring of complaints and customer satisfaction system (QSP-0821).
b., c. the collection and analysis of product related-data which includes scrap, non-conforming product and trends in these .
d.The company has a system to review the performance of key suppliers.

8.5 Improvement

8.5.1 Continual Improvement

The organization shall continually improve 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 review.

8.5 Improvement

8.5.1 Continual Improvement

The management conducts periodic review meetings to monitor and improve the effectiveness of the quality management system. (QSP-0560)

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define requirements for

1. reviewing nonconformities (including customer complaints),
2. determining the causes of nonconformities,
3. evaluating the need for action to ensure that nonconformities do not recur,
4. determining and implementing action needed,
5. records of the results of action taken (see 4.2.4), and
6. reviewing corrective action taken.

8.5.2 Corrective action

A procedure detailing the required actions following customer complaints (QSP-0852) and non conformities is issued to describe the complaint handling methods, investigation for true causes, actions taken to prevent recurrence, and adequate follow up to check effectiveness.

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for

1. determining potential nonconformities and their causes,
2. evaluating the need for action to prevent occurrence of nonconformities,
3. determining and implementing action needed,
4. records of results of action taken (see 4.2.4), and
5. reviewing preventive action taken.

8.5.3 Preventive action

The company addresses the causes of potential nonconformances and implements appropriate preventive actions to prevent their occurrence (QSP-0853).  These preventive actions may also be an output of Management Review Meetings (QSP-0560)