9 Performance Evaluation

• Monitoring, Measurement, Analysis and Evaluation

• Internal Audit

• Management Review

Monitoring, Measurement, Analysis & Evaluation

Calibration Control 

All instruments used to measure mechanical/physical or dimensional features of purchased material, customer-furnished material or completed product, and processing parameters must be suitable and accurate to assure credibility of each feature measured.

The Maintenance Department or Head of Quality is responsible for identifying the type of instrument capable of performing the required measurement.  Accuracy of each instrument used for final acceptance must be calibrated as required by the instrument manufacturer or by the instrument history.

Calibration standards are traceable to the National Institute of Standards & Technology.  The standards used to verify accuracy must be more sensitive than the instruments being calibrated.

Instruments used for final acceptance features shall be capable of measurements tighter than the specified tolerance and shall be used in a manner that ensures that measurement uncertainty is known and is consistent with the required measurement capability.  

Where test software or comparative references are used, they are checked at prescribed frequencies to ensure they are capable of verifying the acceptability of product.

When specified by contract, technical data pertaining to measurement equipment is made available to the customer for verification that the measurement equipment is functionally adequate.

Instruments found incapable of sustained accuracy will require shorter calibration periods.  An instrument will be withdrawn from use if it is determined to be unstable. 

Control Methodology

The Head of Quality is responsible for determining the measurements to be made and for identifying the type of instrument capable of performing the required measurement.

All inspection, measuring and test equipment, which can affect product quality, is identified on either a computerized or manual calibration log and calibrated at prescribed intervals against standards, which are traceable to the National Institute of Standards & Technology (where no such standards exist, the basis used for calibration is documented in the calibration work instruction).  The calibration log details the equipment type, unique identification number, location, and calibration interval.

Calibration Work Instructions are prepared for all instruments calibrated by JM personnel.  The work instructions detail check methods, acceptance criteria and actions to be taken when results are unsatisfactory.

All equipment used for acceptance measurements are serialized and a certification decal attached where practical.  When attaching a certification decal is not practical, QA has responsibility for ensuring equipment calibration. A calibration record is prepared and maintained for each such instrument.  The record reflects in-service dates, calibration method and frequency.  Accuracy of each instrument used for final acceptance must be calibrated, as required, by the instrument manufacturer or by the instrument history.

Suitable environmental conditions are used for calibrations, inspections, measurements and tests being carried out.

Inspection, measuring and test equipment is handled and stored as to maintain accuracy and fitness for use. Calibrated equipment and calibration standards are safeguarded to prevent adjustments, which would invalidate the calibration settings.

Inspection, Measuring, and Test Equipment Records

Data is maintained for calibration control, inspection, measuring and test equipment records.

Material considered suspect due to instrument malfunction or calibration integrity is investigated so as to identify material accepted with the affected instrument.  If a determination is made that a customer may have received suspect material, JM immediately contacts the customer to determine appropriate measures.

Responsibility

All measuring and test equipment used to calibrate/test customer products or processing are calibrated and maintained.  Responsibility for maintaining the calibration system, including records containing as-found readings and instrument condition, is assigned to the Maintenance Department or Quality Representative.

Customer Satisfaction

Jemison Metals uses Customer Feedback (Scorecards, Customer Complaints, Customer Returns, On Time Delivery, New Business Awards, Customer Meetings) to determine trends in customer satisfaction and dissatisfaction. Results of customer feedback are reviewed at management review meetings and where appropriate, action is determined.

Analysis and Evaluation of Data

Jemison Metals relies on qualitative and quantitative measures as evidence that the QMS is working and to promote continual improvement. These measures are used to assess company-wide performance.

Top Management is responsible for identifying the need and establishing applications for statistical techniques through the quality planning process.  They are continuously evaluated and adjusted based upon changing Jemison and customer needs.  The results of analysis are used to evaluate: a) conformity of products and services; b) the degree of customer satisfaction; c) the performance and effectiveness of the QMS; d) if planning has been implemented effectively; e) the effectiveness of actions taken to address risks and opportunities; f) the performance of external providers; g) the need for improvements to the QMS.

Internal Audit

Internal auditing is an essential element of Jemison Metals’ Quality Management System.  Verification of all levels of the Quality Management System documentation is conducted by personnel independent of activity being audited.

An Audit schedule is established by the Head of Quality, or qualified designee, and is intended to encompass critical areas of the quality and management systems based on the status and importance of the activity being audited and the results of previous audits.  Audit findings are reported and noncompliances are identified.

Corrective action is the most important part of the audit and is directed to the department responsible for system discrepancies.  Both short term and long term solutions along with projected dates for completion are expected.  Follow-up audits are conducted and recorded to confirm effective implementation of the corrective action. The results of internal audits are reviewed by staff members at the Management Review Meeting and are used to identify opportunities for improvement.

Management Review

Top management reviews the organization's quality management system, at least annually, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. Results of internal audits of the QMS, training/resource needs, customer complaints, returned material, areas of product nonconformance, corrective actions, performance of company level objectives, supplier performance, effectiveness of actions to address risks, adequacy of resources, changes to internal and external issues, and any follow-up actions are meeting topics and are considered review inputs. Meeting minutes of the management meeting are considered review outputs.  They also serve as a forum for continual improvement and any important revisions to the system in response to changing markets and technologies.

Jemison Metals’ top management reviews all elements of the Quality Management System on a yearly basis to ensure the continuing suitability and effectiveness in satisfying the requirements of ISO 9001. The review includes resource needs, actions required for the continuing improvement of products relating to customer requirements, as well as quality objectives, quality policy and recommendations for improvement.

Meeting minutes are distributed which highlight corrective actions initiated, or completed, regarding Quality Management System deficiencies and customer concerns.

Applicable Quality Management Procedures and Documents: 

Ø   QMP 7.5   Documented Information    

Ø   QMP 9.2   Internal Audit    

Ø   SOP 3        Control of Monitoring and Measuring Resources

Ø   MOP 1      Management Review

Ø   Calibration Work Instructions

Revision History