8.          MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1       General

MII plans and implements the monitoring, measurement, analysis and improvement processes needed

a.          to demonstrate conformity of the product,

b.          to ensure conformity of the quality management system, and

c.          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.

 

These items are normally determined during Management Review Meetings (see 5.6).

 

8.2       Monitoring and Measurement

8.2.1      Customer Satisfaction

As one of the measurements of the performance of the quality management system, MII monitors information relating to customer perception as to whether MII has met customer requirements. The methods for obtaining and using this information are determined.

 

Sales is responsible to collect this data.  The data is complied, analyzed and presented at the management review meeting.  MII will perform this task once per year. 

 

8.2.2      Internal Audit

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

a.          conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by MII, and

b.          is effectively implemented and maintained.

 

An audit program is planned, and takes 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 are defined. Selection of auditors and conduct of audits ensures 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 Quality Records 4.2.3) is defined in the Internal Audit Procedure (P4.17).

 

The managers responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities includes 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 any similar methods to support audits of the quality management system requirements.

 

The acceptability of the selected tools are measured against the effectiveness of the internal audit process and overall organization performance.

 

Internal audits also meet contract and/or regulatory requirements.

 

8.2.3      Monitoring and Measurement of Processes

MII 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, to ensure conformity of the product.

 

In the event of process nonconformity, MII shall:

a.          take appropriate action to correct the nonconforming process,

b.         evaluate whether the process nonconformity has resulted in product nonconformity, and

c.          identify and control the nonconforming product in accordance with clause 8.3.

 

MII utilizes the Internal Audit System and various records of nonconformances to measure the effectiveness of the quality management system.  These items are presented during management reviews and are consistent with the quality objectives.

 

8.2.4      Monitoring and Measurement of Product

MII 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).

 

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

 

Product is not used until it has been inspected or otherwise verified as conforming to specified requirements, except when product is released under Advance Release of Product procedures pending completion of all required measurement and monitoring activities. (see Procedure P4.10.4.8)

 

Evidence of conformity with the acceptance criteria is maintained with the use of the Work Order.  Records indicate the person(s) authorizing release of product (see Quality Records 4.2.3).

 

Product release and service delivery does not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.

 

8.2.4.1 Inspection Documentation

Measurement requirements for product or service acceptance are documented.  This documentation may be part of the production documentation and includes:

a.          criteria for acceptance and/or rejection,

b.         where in the sequence measurement and testing operations are performed,

c.          a record of the measurement results, and

d.          type of measurement instruments required and any specific instructions associated with their use.

 

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

 

Where required to demonstrate product qualification MII ensures that records provide evidence that the product meets the defined requirements.

 

8.2.4.2 First Article Inspection

MII’ system provides the In-process Inspection Procedure (P4.10) 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.