ISO 9001:2000 Quality Manual (Section 8)
8 Measurement, analysis and improvement
8.1 General
Planning for monitoring, measurement, analysis and improvement activities occurs at two levels:
The product level?ensuring and demonstrating conformity of the product. Production Management is responsible for determining the appropriate production processes and measuring and monitoring activities used during production and inspection in daily operations and the records thereof. Such activities are reviewed during Management Review meetings, where customer satisfaction is analyzed to determine where improvements at the product level can be made.
And second, the system level?ensuring and demonstrating conformity of the quality management system to the requirements of ISO 9001 and to our own established procedures and policies as well as the achievement of objectives. Such planning at the system level includes scheduling Internal Audits and measuring customer satisfaction. It also addresses the continual improvement of the quality management system?s effectiveness and opportunities for preventive action. Top management evaluates the effectiveness of measuring and monitoring activities during Management Review Meetings, where further application of such activities is also considered, including the use of statistical techniques. Any such activities identified are implemented according to the resulting action item plan, which is recorded in the Management Review Meetings Agenda and Minutes. This level of planning is focused upon the measurement of processes, determination of system conformity and upon achieving improvement to the quality management system.
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
Customer satisfaction is considered during Management Review Meetings. Customer satisfaction data is collected and reported using customer feedback data and various satisfaction results. Such data is summarized into reports that are presented to top management for analysis. Top management ensures that data regarding product and process conformance, supplier performance, and customer satisfaction is collected, recorded and analyzed. Although measurements of such performance indicators may be collected as it becomes available, such data is analyzed annually during Management Review Meetings. Customer satisfaction data is a vital tool in driving improvement of the quality management system.
8.2.2 Internal Audits
The company conducts periodic Internal Audits to determine whether or not the quality management system conforms to the requirements of ISO 9001, our internal procedures, and whether or not the system has been effectively implemented and maintained. Such audits are in accordance with the Internal Audit procedure. The procedure defines the requirements for internal auditors, for conducting audits, and for recording the results and reporting them to management.
The Management Representative is responsible for scheduling and managing regular internal quality audits. Every area of the company that affects product quality will be scheduled for internal audits, according to the status and importance of the activities being audited taking into consideration the results from previous audits.
Audits are performed by trained Internal Auditors who are independent of the area being audited. Findings are recorded Using Engineering Change Request system, which are submitted to the Management Representative. The Management Representative ensures that management of the area takes timely corrective action. Once the action is completed, the Management Representative, or designated representative, verifies the effective implementation of Corrective and Preventive Actions during subsequent audits or special follow-up audits. Audit findings and results are reviewed at Management Review Meetings.
8.2.3 Monitoring and measurement of processes
Where applicable, the company has implemented the necessary methods to ensure that our products and services meet the planned results. When the results of the events are not achieved corrective action shall be documented on the applicable Corrective Action Request and actions taken as deemed necessary. Internal audits and management review will be some of the methods used to monitor the processes.
8.2.4 Monitoring and measurement product
According to the associated production procedures, work instructions constitute the quality and inspection plan for each order. Such plans dictate where in the process inspections are to take place as well as the acceptance criteria associated with the inspections. Records of production and inspection activities required by such quality plans remain with documents throughout production and shipping, after which they are maintained according to the Record Retention Form. These indicate the Operator authorizing the release of product to subsequent operations or to Finished Goods Inventory or the customer. These documents also demonstrate conformity with the acceptance criteria. Product is not released to the customer until all planned arrangements have been satisfactorily completed unless otherwise approved by the customer.
8.3 Control of Non-conforming Product
All products found to be non-conforming to specified requirements, are identified by marking the non-conformity and/or segregating the product while awaiting disposition per procedure SQ00xx.
Non-conformities discovered during receiving or receiving inspection are treated according to the non-conforming product procedure contained in the Receiving and Receiving Inspection procedure. Non-conformities discovered during production or inspections are treated according to the non-conforming product procedure contained in the Production procedure.
All employees are authorized to mark, tag and/or segregate nonconforming product to prevent unintended use while disposition is being determined, and to control further processing until the unsatisfactory condition has been corrected. Disposition will be determined and recorded as described in the associated procedure. Corrective and Preventive Actions will be initiated as deemed appropriate.
Non-conforming product is corrected, when practical, and is re-inspected against the criteria against which it originally failed. Products that do not conform to specified requirements may be offered to customers for concession. Such concessions are negotiated by Sales personnel or the President, who ensure that the actual condition of the products are documented and communicated to the customer. If non-conforming product is detected only after delivery or use has started, the Sales personnel and/or the Management Representative will ensure that all affected parties are aware of the non-conformity, as appropriate.
8.4 Analysis of data
Data demonstrating the suitability and effectiveness of the quality management system as well as that used to evaluate where continual improvement of the quality management system can be made is presented and analyzed during Management Review meetings. Data presented during the meeting includes data resulting from monitoring and measuring product, process and customer satisfaction and other relevant sources.
Information resulting from these analyses includes customer satisfaction levels, conformity of product to requirements, characteristics and trends of processes and products including opportunities for preventive action, and supplier performance.
8.5 Improvement
8.5.1 Continual improvement
ACME will continually improve the effectiveness of the quality management system through use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. Continual improvement activities will be reviewed during management review meetings and will be documented on the Corrective Action Request form.
8.5.2 Corrective Action
Corrective Actions are undertaken to eliminate the causes of non-conformities in order to prevent their recurrence. Actions taken are appropriate to the impact of the problems encountered. Corrective Actions may be initiated by anyone in the company according to the Corrective and Preventive Actions procedure. Such actions will be recorded and processed using a Corrective Action Request form. Any resulting changes to processes and procedures will be reflected in the appropriate documents.
Corrective Actions may arise from a variety of sources, including Management Review Meetings, Internal Audits, Customer Complaints, and any identification of nonconformity. The Management Representative will review all requests for Corrective Actions to determine the feasibility of the requested actions and to assign responsibilities for determining the problem?s root cause and evaluating the appropriate actions to ensure that the nonconformity does not recur. Corrective action will be determined and implemented accordingly and the results will be recorded in the Quality system database on the vault.
Upon completion of a Corrective Action, the person responsible for the action will record its completion on the Engineering Change Form.
8.5.3 Preventive Action
Proposals for Preventive Actions may arise in the same manner as those for Corrective Actions, although Preventive Actions are undertaken to eliminate causes of potential non-conformities. Such proposals will be processed in a similar manner as Corrective Actions. Also, whenever corrective actions are implemented, consideration is always given to determine steps needed to initiate preventive action to prevent potential non-conformities in similar situations. Preventive actions may be initiated independently of a corrective action in order to prevent potential non-conformities. Preventive actions and their verification are maintained in the quality system database.
Data regarding the status of Corrective Action, Preventive Action, and Continual Improvement is reviewed during Management Review Meetings to make sure that the quality of our products is adequate and that improvements are implemented where needed. During the meeting, Preventive Actions may be determined and implemented to ensure that potential problems are prevented. Records of such actions to be taken are recorded in the Management Review Meeting Agenda and Minutes and/or in Corrective Action Request forms.
Associated documents/records for section 8:
Management Review Meetings procedure, SQ00xx
Management of Non-Conforming Materials, SQ00xx
Internal Audits procedure, SQ00xx
Corrective and Preventive Action procedure-ECR/ECO, SQ00xx